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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01493284
Ethics application status
Date submitted
5/12/2011
Date registered
15/12/2011
Date last updated
4/02/2019

Titles & IDs
Public title
Portico TAVI Implant With Transfemoral Delivery System
Scientific title
Assessment Of The St. Jude Medical Porticoâ„¢ 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 - Number of participants that reported all cause mortality
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Number of Select Cardiovascular Adverse Events - Number of participants with select cardiovascular adverse events
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Participant NYHA Classification at Day 30 - The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
Timepoint [2] 0 0
day 30
Secondary outcome [3] 0 0
Number of Participants With Acute Device Success - Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system
Correct position of the device in the proper anatomical location
Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR)
Only one valve implanted in the proper anatomical location
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
Gender
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
N/A
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
The purpose of this study is to assess the safety and effectiveness of the SJM Portico
Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in
subjects with severe symptomatic aortic stenosis (AS).
Trial website
https://clinicaltrials.gov/show/NCT01493284
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

Summary results
Other publications