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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01493284




Registration number
NCT01493284
Ethics application status
Date submitted
5/12/2011
Date registered
15/12/2011

Titles & IDs
Public title
Portico TAVI Implant With Transfemoral Delivery System
Scientific title
Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
Secondary ID [1] 0 0
1105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcatheter Aortic Valve Implantation

Experimental: Transfemoral Access - Transfemoral Access for transcatheter aortic valve implant


Treatment: Devices: Transcatheter Aortic Valve Implantation
Placement of the SJM Portico aortic valve with a transfemoral delivery system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All Cause Mortality
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Number of Select Cardiovascular Adverse Events
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Participant NYHA Classification at Day 30
Timepoint [2] 0 0
day 30
Secondary outcome [3] 0 0
Number of Participants With Acute Device Success
Timepoint [3] 0 0
7 days

Eligibility
Key inclusion criteria
1. Subject has given written study Informed Consent for participation prior to procedure.
2. Subject is = 18 years of age or legal age in host country.
3. Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.
4. Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index = 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
6. Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
7. Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
8. In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
9. Subject has structurally normal cardiac anatomy.
10. Subject is willing and able to comply with all required follow-up evaluations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (=180 days) of the index procedure.
2. Subject has carotid artery disease requiring intervention.
3. Subject has evidence of a myocardial infarction (MI) within the past 6 months (=180 days) of the index procedure.
4. Subject has hypertrophic cardiomyopathy.
5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
6. Subject has mitral or tricuspid valvular regurgitation (>grade III) or moderate to severe mitral stenosis.
7. Subject has aortic root angulation >70 degrees (horizontal aorta).
8. Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
9. Subject refuses blood transfusion or surgical valve replacement.
10. Subject has left ventricular ejection fraction (LVEF) < 20%.
11. The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
12. Subject has severe basal septal hypertrophy.
13. Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure = 14 days of the index procedure.
14. Subject has a history of or has active endocarditis.
15. Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
16. Subject has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
18. Subject with significant pulmonary disease.
19. Subject has significant chronic steroid use.
20. Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
21. Subject has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.
22. Subject has morbid obesity defined as BMI = 40.
23. Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.
24. Subject has ongoing infection or sepsis.
25. Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
26. Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
27. Subject has significant aortic disease, including:

* aortic abdominal aneurysm (AAA) = 4cm
* thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)
* marked tortuosity
* significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta
* severe tortuosity of the thoracic aorta.
28. Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
29. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure.
30. Subject is currently participating in another investigational drug or device study.
31. Subject requires emergency surgery for any reason.
32. Subject has a life expectancy < 12 months.
33. Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.
34. Subject is suffering from dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
35. Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide Royal Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Germany
State/province [2] 0 0
Bad Nauheim
Country [3] 0 0
Germany
State/province [3] 0 0
Bernau
Country [4] 0 0
Germany
State/province [4] 0 0
Hamburg
Country [5] 0 0
Germany
State/province [5] 0 0
Jena
Country [6] 0 0
Germany
State/province [6] 0 0
Karlsruhe
Country [7] 0 0
Germany
State/province [7] 0 0
Leipzig
Country [8] 0 0
Netherlands
State/province [8] 0 0
Leeuwarden
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Northern Ireland
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Leicester
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ganesh Manoharan, MD
Address 0 0
Royal Victoria Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01493284