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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05002088
Registration number
NCT05002088
Ethics application status
Date submitted
27/07/2021
Date registered
12/08/2021
Date last updated
28/02/2025
Titles & IDs
Public title
Portico Valve-in-Valve Retrospective Registry
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Scientific title
Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use
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Secondary ID [1]
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ABBOTT-CIP-10414
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis
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Aortic Valve Failure
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Aortic Insufficiency
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Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Other
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Transcatheter Aortic Valve Replacement
Primary Analysis Population - The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (=19 mm and =27 mm).
Exploratory Registry Arm - The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm.
Treatment: Devices: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication.
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Assessment method [1]
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Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications
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Timepoint [1]
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30 days post index procedure
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Primary outcome [2]
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Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.
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Assessment method [2]
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Composite of all-cause mortality or disabling stroke.
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Timepoint [2]
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1 year post index procedure
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Secondary outcome [1]
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Number of Participants With Procedural Success
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Assessment method [1]
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Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system
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Timepoint [1]
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Procedure
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Secondary outcome [2]
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Evaluation of Adverse Event Rates (Descriptive Endpoint)
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Assessment method [2]
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis.
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Timepoint [2]
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30 days post index procedure
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Secondary outcome [3]
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0
Evaluation of Adverse Event Rates (Descriptive Endpoint)
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Assessment method [3]
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis.
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Timepoint [3]
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1 year post index procedure
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Secondary outcome [4]
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0
Evaluation of Adverse Event Rates (Descriptive Endpoint)
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Assessment method [4]
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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Timepoint [4]
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2 years post index procedure
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Secondary outcome [5]
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0
Evaluation of Adverse Event Rates (Descriptive Endpoint)
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Assessment method [5]
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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Timepoint [5]
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3 years post index procedure
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Secondary outcome [6]
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0
Evaluation of Adverse Event Rates (Descriptive Endpoint)
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Assessment method [6]
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All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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Timepoint [6]
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4 years post index procedure
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Secondary outcome [7]
0
0
Evaluation of Adverse Event Rates (Descriptive Endpoint)
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Assessment method [7]
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0
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
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Timepoint [7]
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5 years post index procedure
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Secondary outcome [8]
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Assessment of Clinical Benefit Endpoint - NYHA Class
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Assessment method [8]
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0
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
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Timepoint [8]
0
0
30 days post index procedure
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Secondary outcome [9]
0
0
Assessment of Clinical Benefit Endpoint - NYHA Class
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Assessment method [9]
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0
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
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Timepoint [9]
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0
1 year post index procedure
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Secondary outcome [10]
0
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Assessment of Clinical Benefit Endpoint - NYHA Class
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Assessment method [10]
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0
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
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Timepoint [10]
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0
2 years post index procedure
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Secondary outcome [11]
0
0
Assessment of Clinical Benefit Endpoint - NYHA Class
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Assessment method [11]
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0
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
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Timepoint [11]
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0
3 years post index procedure
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Secondary outcome [12]
0
0
Assessment of Clinical Benefit Endpoint - NYHA Class
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Assessment method [12]
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0
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
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Timepoint [12]
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0
4 years post index procedure
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Secondary outcome [13]
0
0
Assessment of Clinical Benefit Endpoint - NYHA Class
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Assessment method [13]
0
0
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
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Timepoint [13]
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0
5 years post index procedure
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Secondary outcome [14]
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0
Paravalvular Leak as Measured by Core Lab Echocardiography
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Assessment method [14]
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Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
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Timepoint [14]
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30 Days
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Secondary outcome [15]
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0
Paravalvular Leak as Measured by Core Lab Echocardiography
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Assessment method [15]
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Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
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Timepoint [15]
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0
1 Year
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Secondary outcome [16]
0
0
Paravalvular Leak as Measured by Core Lab Echocardiography
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Assessment method [16]
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Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
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Timepoint [16]
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0
2 Years
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Secondary outcome [17]
0
0
Paravalvular Leak as Measured by Core Lab Echocardiography
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Assessment method [17]
0
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Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
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Timepoint [17]
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0
3 Years
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Secondary outcome [18]
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Paravalvular Leak as Measured by Core Lab Echocardiography
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Assessment method [18]
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Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
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Timepoint [18]
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4 Years
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Secondary outcome [19]
0
0
Paravalvular Leak as Measured by Core Lab Echocardiography
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Assessment method [19]
0
0
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
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Timepoint [19]
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0
5 Years
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Secondary outcome [20]
0
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Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
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Assessment method [20]
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [20]
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0
30 days
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Secondary outcome [21]
0
0
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
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Assessment method [21]
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [21]
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0
1 year
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Secondary outcome [22]
0
0
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
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Assessment method [22]
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [22]
0
0
2 Years
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Secondary outcome [23]
0
0
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
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Assessment method [23]
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [23]
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3 Years
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Secondary outcome [24]
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0
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
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Assessment method [24]
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [24]
0
0
4 Years
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Secondary outcome [25]
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0
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
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Assessment method [25]
0
0
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [25]
0
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5 Years
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Secondary outcome [26]
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Aortic Valve Area as Measured by Core Lab Echocardiography
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Assessment method [26]
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [26]
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0
30 days
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Secondary outcome [27]
0
0
Aortic Valve Area as Measured by Core Lab Echocardiography
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Assessment method [27]
0
0
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [27]
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1 Year
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Secondary outcome [28]
0
0
Aortic Valve Area as Measured by Core Lab Echocardiography
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Assessment method [28]
0
0
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [28]
0
0
2 Years
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Secondary outcome [29]
0
0
Aortic Valve Area Measured by Core Lab Echocardiography
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Assessment method [29]
0
0
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [29]
0
0
3 Years
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Secondary outcome [30]
0
0
Aortic Valve Area as Measured by Core Lab Echocardiography
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Assessment method [30]
0
0
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [30]
0
0
4 Years
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Secondary outcome [31]
0
0
Aortic Valve Area as Measured by Core Lab Echocardiography
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Assessment method [31]
0
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Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
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Timepoint [31]
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0
5 Years
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Secondary outcome [32]
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0
New Pacemaker Implant
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Assessment method [32]
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New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.
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Timepoint [32]
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0
30 days
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Secondary outcome [33]
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0
New Pacemaker Implant
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Assessment method [33]
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New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.
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Timepoint [33]
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1 year
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Eligibility
Key inclusion criteria
1. Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic stenosis, severe regurgitation, or a combination of at least moderate stenosis with at least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria.
2. Surgical bioprosthesis true inner diameter (true ID) was = 19 mm and = 27 mm and was confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR website https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal echocardiogram (TEE) will be accepted for sizing.
3. Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.
4. Subject provided written informed consent prior to performing data collection for study specific visits. For patients that are deceased at the time of enrollment, all institutional/local legal and regulatory requirements for consent must be met prior to enrollment and data collection.
5. Subject is = 18 years of age or legal age in host country at the time of consent.
6. Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV.
7. Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or a minimum of 5.0 mm for the FlexNav™ delivery system.
8. Subject had the Portico or FlexNav delivery system enter their vasculature
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention =30 days prior to Portico ViV index procedure (MI defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
2. Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC<3,000 mm3), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <50,000 cells/mm³).
3. Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
4. Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
5. Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
6. Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding =3 months prior to ViV index procedure.
7. Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) =6 months prior to index procedure.
8. Subject had renal insufficiency (serum creatinine >3.0 mg/dL (265.5µmol/L)) and/or end stage renal disease requiring chronic dialysis.
9. Subject had active bacterial endocarditis or ongoing sepsis = 6 months prior to the index procedure.
10. Surgical aortic bioprosthetic valve was unstable or rocking.
11. Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible.
12. Subject was unable to tolerate antiplatelet or anticoagulant therapy
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/12/2023
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Sample size
Target
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Accrual to date
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Final
71
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
GenesisCare - St Andrew's Hospital & GenesisCare Leabrook - Satellite Site of GenesisCare - Wesley Hospital - Adelaide
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Recruitment hospital [2]
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0
GenesisCare - Wesley Hospital - Auchenflower
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Recruitment postcode(s) [1]
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0
- Adelaide
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Recruitment postcode(s) [2]
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0
QLD 4066 - Auchenflower
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Recruitment outside Australia
Country [1]
0
0
Denmark
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State/province [1]
0
0
Copenhagen
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Country [2]
0
0
Germany
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State/province [2]
0
0
Bad Nauheim
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Country [3]
0
0
Germany
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State/province [3]
0
0
Rostock
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Country [4]
0
0
United Kingdom
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State/province [4]
0
0
London
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Country [5]
0
0
United Kingdom
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State/province [5]
0
0
Morriston
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
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Trial website
https://clinicaltrials.gov/study/NCT05002088
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Barathi Sethuraman
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Address
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0
Abbott
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/88/NCT05002088/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/88/NCT05002088/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05002088
Download to PDF