Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry

Sponsor

Symetis SA (Industry)

Overall Status

Completed

CT.gov ID

NCT02306226

Collaborator

(none)

1,000

Enrollment

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Apr 1, 2017

Outcome Measures

Primary Outcome Measures

Rate of all-cause mortality [30 days]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
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 neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.