ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Symptomatic Aortic Stenosis
- Sponsor
- Symetis SA
- Enrollment
- 250
- Locations
- 17
- Primary Endpoint
- Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.
Detailed Description
A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has severe aortic stenosis
- •Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
- •Patient willing to participate in the study and provides signed EC-approved informed consent
- •The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Exclusion Criteria
- •Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
Outcomes
Primary Outcomes
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
Time Frame: 30 days and 12 Months Follow-up
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant . MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.
Secondary Outcomes
- Device success at 30 days and 12 Months follow-up(30 days and 12 Months follow-up)
- Procedural Success post-implantation (up to 24 hours after device implantation)(Post-Implantation (up to 24 hours after device implantation))