Aortic Stenosis
Conditions
Keywords
TAVI, Aortic Stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transapical Access
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 collect continued surveillance data pertaining to safety and performance of the device.
Detailed description
The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™. The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open surgery is considered to be associated with high surgical risk. The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.
Interventions
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.
Sponsors
Symetis SA
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause mortality at 30 days follow-up | 30-Day Follow-up | Rate of all-cause mortality at 30 days follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical endpoints (VARC II) at 30 days and 12 months | 30-Days and 12 Months Follow-up | Rate of clinical endpoints (VARC II) at 30 days and 12 months: * Mortality * Stroke * Myocardial infarction * Bleeding complication * Acute kidney injury * Vascular complication * Conduction disturbances and arrhythmia * Other TAVI-related complications |
| Procedural success post-implant | Procedure to 24h Post-implantation | Procedural success post-implant defined as ACURATE TA™ implanted in intended location with the following criteria: * Insufficiency \< +3 * Mean aortic gradient \< 20 mmHg * EOA ≥ 1.0 cm2 * No valve-in-valve or conversion to surgery performed |
| Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up | 7-Days Follow-up and 12-Months Follow-up | Device success analyzed by ECHO measurement at 7 days or discharge (whichever occurs first) and at 12 months follow-up and defined as the following criteria: * ACURATE TA™ implanted in intended location * No impingement of the mitral valve * Normal coronary blood flow * Valve-in-valve insufficiency \< +3 * Mean gradient \< 20mmHg * EOA ≥ 1.0 cm2 * No valve-in-valve or conversion to surgery performed |
| Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months | 30-Day and 12-Month Follow-up | Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up. |
Countries
Austria, Germany, Italy, Switzerland
Outcome results
None listed