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
  Purpose

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 Intervention
Symptomatic Aortic Stenosis
Device: Transcatheter Aortic Valve Implantation (TAVI)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 10
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving TAVI valve Device: Transcatheter Aortic Valve Implantation (TAVI)
Placement of the SJM TAVI aortic valve with a transfemoral delivery system.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01487330

Locations
United Kingdom
Royal Victoria Hospital
Belfast, 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: NCT01487330     History of Changes
Other Study ID Numbers: 1103
Study First Received: August 1, 2011
Last Updated: August 5, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on August 21, 2014