First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Assessment of Technical Feasibility and Device Deployment Characteristics
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written Informed Consent for participation prior to procedure.
- •Legal age in host country.
- •Aortic annulus 19-21mm diameter
- •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)
- •NYHA Functional Classification of II or greater.
- •Predicted operative mortality or serious, irreversible morbidity risk is \<50% at 30 days.
- •Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
Exclusion Criteria
- •History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
- •Carotid artery disease requiring intervention.
- •Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
- •Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- •Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
- •Aortic root angulation \>70 degrees (horizontal aorta).
- •Pre-existing prosthetic valve or prosthetic ring in any position. LVEF \< 20%.
- •Untreated coronary artery disease (CAD) requiring revascularization.
- •Severe basal septal hypertrophy.
- •Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
Outcomes
Primary Outcomes
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 Outcomes
- Quantification of SAEs Reported (Device Related or Procedure Related)(Through 12 months post implantation)