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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03752866
Registration number
NCT03752866
Ethics application status
Date submitted
15/11/2018
Date registered
26/11/2018
Date last updated
21/10/2024
Titles & IDs
Public title
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
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Scientific title
CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
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Secondary ID [1]
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SJM-CIP-CL1003491
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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:
Symptomatic Degenerative Aortic Stenosis
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Severe Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Other
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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
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Portico™ Valve, Portico Delivery System(s) and Loading System(s)
Treatment: Devices - Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
Experimental: Portico™ Valve, Delivery System(s) and Loading System(s) - Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system will be included.
Experimental: Portico™ Valve, FlexNav Delivery and Loading System(s) - Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems will be included.
Treatment: Devices: Portico™ Valve, Portico Delivery System(s) and Loading System(s)
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.
Treatment: Devices: Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.
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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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Cardiovascular Mortality
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Assessment method [1]
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Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
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Timepoint [1]
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30 days from the index procedure
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Secondary outcome [1]
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Number of Subjects With Myocardial Infarction
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Assessment method [1]
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Timepoint [1]
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At 30 days
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Secondary outcome [2]
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Number of Subjects With Stroke
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Assessment method [2]
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Timepoint [2]
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At 30 days
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Secondary outcome [3]
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Number of Subjects With Bleeding Events
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Assessment method [3]
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Timepoint [3]
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At 30 days
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Secondary outcome [4]
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Number of Subjects With Acute Kidney Injury
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Assessment method [4]
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The increase in creatinine must occur within 48 hours. Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \<0.5 mL/kg per hour for \>6 but \<12 hours. Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \<0.5 mL/kg per hour for \>12 but \<24 hours. Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of = 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for =24 hours or anuria for =12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
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Timepoint [4]
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At 30 days
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Secondary outcome [5]
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Number of Subjects With Vascular Complications
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Assessment method [5]
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Timepoint [5]
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At 30 days
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Secondary outcome [6]
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Number of Subjects With Annular Rupture
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Assessment method [6]
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Timepoint [6]
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At 30 days
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Secondary outcome [7]
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Number of Subjects With Coronary Obstruction
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Assessment method [7]
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Timepoint [7]
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At 30 days
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Secondary outcome [8]
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Number of Subjects Undergoing Conversion To Open Surgery
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Assessment method [8]
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Timepoint [8]
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At 30 days
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Secondary outcome [9]
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Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment
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Assessment method [9]
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Timepoint [9]
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At 30 days
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Secondary outcome [10]
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Number Of Subjects With Valve Embolization
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Assessment method [10]
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Timepoint [10]
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At 30 days
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Secondary outcome [11]
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Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion
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Assessment method [11]
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Timepoint [11]
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At 30 days
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Secondary outcome [12]
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Vessel Diameter
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Assessment method [12]
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Timepoint [12]
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At 30 days
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Secondary outcome [13]
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Introducer Sheath Used
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Assessment method [13]
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This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).
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Timepoint [13]
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At 30 days
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Secondary outcome [14]
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Implant Success
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Assessment method [14]
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Timepoint [14]
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At 30 days
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Secondary outcome [15]
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Effective Orifice Area
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Assessment method [15]
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Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.
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Timepoint [15]
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At 30 days
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Secondary outcome [16]
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Aortic Valve Mean Gradient
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Assessment method [16]
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Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.
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Timepoint [16]
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At 30 days
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Secondary outcome [17]
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Number of Subjects With Paravalvular Leak (PVL)
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Assessment method [17]
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Timepoint [17]
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At 30 days
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Secondary outcome [18]
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NYHA Classification
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Assessment method [18]
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NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).
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Timepoint [18]
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At 30 days
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Secondary outcome [19]
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EQ5D-3L Visual Analog Scale Value
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Assessment method [19]
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The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."
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Timepoint [19]
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At 30 days
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Secondary outcome [20]
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Kaplan-Meier Rate of All-cause Mortality
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Assessment method [20]
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Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.
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Timepoint [20]
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At 12 months
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Eligibility
Key inclusion criteria
1. Subjects who are =18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
2. Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
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Minimum age
18
Years
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Maximum age
100
Years
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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. Have sepsis, including active endocarditis
2. Have any evidence of left ventricular or atrial thrombus
3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
4. Have a non-calcified aortic annulus
5. Have congenital bicuspid or unicuspid leaflet configuration
6. Are unable to tolerate antiplatelet/anticoagulant therapy
7. Are pregnant at the time of signing informed consent
8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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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
25/10/2018
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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
28/07/2022
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Sample size
Target
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Accrual to date
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Final
1001
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Heart Care Partners- Wesley Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Antwerpen
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Country [2]
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Czechia
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State/province [2]
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Olomouc
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Country [3]
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Germany
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State/province [3]
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Bavaria
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Country [4]
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Germany
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State/province [4]
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Bad Nauheim
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Country [5]
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Germany
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State/province [5]
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Berlin-Mitte
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Country [6]
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Germany
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State/province [6]
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Berlin
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Country [7]
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Germany
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State/province [7]
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Dortmund
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Country [8]
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Germany
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State/province [8]
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Dresden
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Country [9]
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Germany
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State/province [9]
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Frankfurt
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Country [10]
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Germany
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State/province [10]
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Hamburg
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Country [11]
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Germany
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State/province [11]
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Karlsruhe
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Country [12]
0
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Germany
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State/province [12]
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Mainz
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Country [13]
0
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Italy
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State/province [13]
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Lombardy
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Country [14]
0
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Italy
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State/province [14]
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Milano
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Country [15]
0
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Italy
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State/province [15]
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San Donato Milanese
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Country [16]
0
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Italy
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State/province [16]
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Vicenza
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Country [17]
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Poland
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State/province [17]
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Mazovia
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Country [18]
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Spain
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State/province [18]
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Catalonia
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Country [19]
0
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Spain
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State/province [19]
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Huelva
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Country [20]
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Spain
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State/province [20]
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Madrid
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Country [21]
0
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Switzerland
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State/province [21]
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Aarau
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Country [22]
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United Kingdom
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State/province [22]
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Ireland
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Country [23]
0
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United Kingdom
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State/province [23]
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North East England
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Country [24]
0
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United Kingdom
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State/province [24]
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Swansea
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Country [25]
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United Kingdom
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State/province [25]
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London
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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 purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
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Trial website
https://clinicaltrials.gov/study/NCT03752866
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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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Helge Möllmann
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Address
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St. Johannes Hospital, Dortmund, Germany
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/66/NCT03752866/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/66/NCT03752866/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/NCT03752866
Download to PDF