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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01487330
First received: August 1, 2011
Last updated: August 5, 2014
Last verified: August 2014

August 1, 2011
August 5, 2014
August 2011
October 2011   (final data collection date for primary outcome measure)
Assessment of Technical Feasibility and Device Deployment Characteristics [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01487330 on ClinicalTrials.gov Archive Site
Quantification of SAEs Reported (Device Related or Procedure Related) [ Time Frame: Through 12 months post implantation ] [ Designated as safety issue: Yes ]

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
Quantification of SAEs Reported (Device Related or Procedure Related) [ Time Frame: At procedure, discharge, 30 day, 3 mo, 6 mo, 12 mo follow-up ] [ Designated as safety issue: Yes ]

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
Not Provided
Not Provided
 
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Symptomatic Aortic Stenosis
Device: Transcatheter Aortic Valve Implantation (TAVI)
Placement of the SJM TAVI aortic valve with a transfemoral delivery system.
Experimental: Subjects receiving TAVI valve
Intervention: Device: Transcatheter Aortic Valve Implantation (TAVI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01487330
1103
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Ganesh Manoharan, MD Royal Victoria Hospital
St. Jude Medical
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP