Clinical trial NCT02306226: Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Official title: Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: TAVI
Aortic stenosis
Transcatheter aortic valve replacement
Transcatheter aortic valve implantation
Transfemoral access
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As the ACURATE neo™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the Instructions For Use.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of all-cause mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Rate of clinical endpoints (VARC 2)
timeFrame: Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months
measure: Procedural success
timeFrame: Post-implantation
measure: Device success
timeFrame: 7 days or discharge (whichever occurs first), 12 months
measure: Functional improvement from baseline as per NYHA Functional Classification at 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up
timeFrame: 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up
Locations:
Study officials:
affiliation: Kerckhoff Klinik
name: Helge Möllmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References: