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Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) and SJM TAVI Transfemoral Delivery System (Portico TF EU)

This study has suspended participant recruitment.
(SJM has suspended TAVR implants to evaluate reports of reduced leaflet mobility.)
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01493284
First received: December 5, 2011
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Symptomatic Aortic Stenosis
Device: Transcatheter Aortic Valve Implantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event rates [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    The event rates at 30 days of the following:

    • Cardiovascular mortality
    • Myocardial Infarction (MI)
    • Disabling (Major) Stroke
    • Non-Disabling (Minor) Stroke
    • Acute kidney injury (AKI)
    • Vascular access site and access-related complications
    • Bleeding
    • Composite of periprocedural encephalopathy, all stroke, and all TIA

  • Functional improvement from baseline [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    1. NYHA Functional Classification
    2. Six Minute Walk Test
    3. Effective Orifice Area (EOA)

  • Acute Device success [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system
    2. Correct position of the device in the proper anatomical location
    3. 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)
    4. Only one valve implanted in the proper anatomical location


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter Aortic Valve Implantation
    Placement of the SJM Portico aortic valve with a transfemoral delivery system
Detailed Description:

Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have severe, symptomatic aortic stenosis

Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493284

Locations
Germany
Kerckhoff Klinik
Bad Nauheim, Germany
Asklepios Klinik-St. Georg
Hamburg, Germany
Herzzentrum Leipzig
Leipzig, Germany
United Kingdom
Royal Victoria Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Glenfield Hospital
Leicester, United Kingdom
Kings College
London, United Kingdom
St. Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Ganesh Manoharan, MD Royal Victoria Hospital
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01493284     History of Changes
Other Study ID Numbers: 1105
Study First Received: December 5, 2011
Last Updated: September 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
aortic stenosis
aortic valve stenosis
valvular heart disease
aortic valve replacement
transcatheter aortic valve implantation
TAVI

Additional relevant MeSH terms:
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on November 20, 2014