Aortic Stenosis
Conditions
Keywords
TAVI, Aortic stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transfemoral access
Brief summary
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device
Detailed description
The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System. The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device. The secondary objective is to evaluate adverse events and device performance of the newly marketed device.
Interventions
None listed
Sponsors
Symetis SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use 2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry 3. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Exclusion criteria
1\. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of all-cause mortality | 30 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical endpoints (VARC 2) | Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months | * Mortality * Stroke * Myocardial infarction * Bleeding complication * Acute kidney injury * Vascular complication * Conduction disturbances and arrhythmia * Other TAVI-related complications |
| Procedural success | Post-implantation | Procedural success defined as ACURATE neo™ implanted in intended location with: * Valve insufficiency \< Grade 3 * Mean aortic gradient \< 20 mmHg * EOA ≥ 1.0 cm2 * No valve-in-valve or conversion to surgery performed * No intra-procedure mortality |
| Device success | 7 days or discharge (whichever occurs first), 12 months | Device success as defined as: * ACURATE neo™ implanted in intended location * No impingement of the mitral valve * Normal coronary blood flow * Valve insufficiency \< Grade 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 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up | 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up | — |
Outcome results
None listed