First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System (SJM TAVI FIH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01487330
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:

The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS).

This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.

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

Detailed Description:
Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)
Study Start Date : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Subjects receiving TAVI valve Device: Transcatheter Aortic Valve Implantation (TAVI)
Placement of the SJM TAVI aortic valve with a transfemoral delivery system.

Primary Outcome Measures :
  1. Assessment of Technical Feasibility and Device Deployment Characteristics [ Time Frame: At time of procedure ]

    Evaluate the technical feasibility and device deployment characteristics (observed at procedure) by:

    1. The ability for the valve to be deployed at the desired location
    2. The ability to complete the full procedure
    3. Quantification of the time from delivery system entry to a fully deployed and functional valve

Secondary Outcome Measures :
  1. Quantification of SAEs Reported (Device Related or Procedure Related) [ Time Frame: Through 12 months post implantation ]

    Evaluate the safety of the 23mm SJM Transcatheter Aortic Heart Valve and transfemoral delivery system by:

    1. Summarizing the SAEs observed at procedure that are device or procedure related
    2. Summarizing the SAEs observed during the study

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Written Informed Consent for participation prior to procedure.
  2. Legal age in host country.
  3. Aortic annulus 19-21mm diameter
  4. Senile degenerative aortic stenosis with 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)
  5. NYHA Functional Classification of II or greater.
  6. Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
  7. Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.

Exclusion Criteria:

  1. History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
  2. Carotid artery disease requiring intervention.
  3. Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
  4. Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
  5. Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
  6. Aortic root angulation >70 degrees (horizontal aorta).
  7. Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%.
  8. Untreated coronary artery disease (CAD) requiring revascularization.
  9. Severe basal septal hypertrophy.
  10. Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
  11. Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation.
  12. Evidence of intracardiac mass, thrombus, or vegetation.
  13. Hemodynamic instability
  14. Significant pulmonary disease.
  15. Nonreactive pulmonary hypertension.
  16. Chronic steroid use.
  17. Hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
  18. Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis.
  19. Morbid obesity defined as BMI ≥ 35.
  20. Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass.
  21. Ongoing infection or sepsis.
  22. Blood dyscrasias
  23. Significant aortic disease.
  24. Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
  25. Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.

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 identifier (NCT number): NCT01487330

United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Ganesh Manoharan, MD Royal Victoria Hospital

Responsible Party: St. Jude Medical Identifier: NCT01487330     History of Changes
Other Study ID Numbers: 1103
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

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

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