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Portico TAVI Implant With Transfemoral Delivery System

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ClinicalTrials.gov Identifier: NCT01493284
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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).

Condition or disease Intervention/treatment Phase
Symptomatic Aortic Stenosis Device: Transcatheter Aortic Valve Implantation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
Study Start Date : December 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transfemoral Access
Transfemoral Access for transcatheter aortic valve implant
Device: Transcatheter Aortic Valve Implantation
Placement of the SJM Portico aortic valve with a transfemoral delivery system




Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 30 days ]
    Number of participants that reported all cause mortality


Secondary Outcome Measures :
  1. Number of Select Cardiovascular Adverse Events [ Time Frame: 30 days ]
    Number of participants with select cardiovascular adverse events

  2. Participant NYHA Classification at Day 30 [ Time Frame: 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.


  3. Number of Participants With Acute Device Success [ Time Frame: 7 days ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493284


Locations
Australia
Adelaide Royal Hospital
Adelaide, Australia
Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark
Germany
Kerckhoff Klinik
Bad Nauheim, Germany
Heart Center Bernau
Bernau, Germany
Asklepios Klinik-St. Georg
Hamburg, Germany
Klinikum der Universität Jena
Jena, Germany
Klinik fur Herzhirurgie Karlruhe GmbH
Karlsruhe, Germany
Herzzentrum Leipzig
Leipzig, Germany
Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
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
Derriford Hospital, Plymouth
Plymouth, United Kingdom
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Ganesh Manoharan, MD Royal Victoria Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01493284     History of Changes
Other Study ID Numbers: 1105
First Posted: December 15, 2011    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction