Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry (SAVI TF)

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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of all-cause mortality	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical endpoints (VARC 2)	Mortality; Stroke; Myocardial infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications	Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months
Procedural success	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	Post-implantation
Device success	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	7 days or discharge (whichever occurs first), 12 months
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

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Helge Möllmann, Prof., Kerckhoff Klinik

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: TAVI; Aortic stenosis; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; Transfemoral access
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2013-05 (Other Identifier: Assistance Publique Hôpitaux de Marseille)