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Trial details imported from ClinicalTrials.gov
Ethics application status
Portico TAVI Implant With Transfemoral Delivery System
Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
Universal Trial Number (UTN)
Symptomatic Aortic Stenosis
Diseases of the vasculature and circulation including the lymphatic system
Research that is not of generic health relevance and not applicable to specific health categories listed above
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 
Comparator / control treatment
Primary outcome 
All Cause Mortality - Number of participants that reported all cause mortality
Secondary outcome 
Number of Select Cardiovascular Adverse Events - Number of participants with select cardiovascular adverse events
Secondary outcome 
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.
Secondary outcome 
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
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
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.
Both males and females
Can healthy volunteers participate?
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
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
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
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
35. Subject has a known allergy to contrast media, nitinol alloys, porcine tissue, or
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Adelaide Royal Hospital - Adelaide
Recruitment postcode(s) 
Primary sponsor type
Abbott Medical Devices
Ethics application status
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 related presentations / publications
Ganesh Manoharan, MD
Royal Victoria Hospital