ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort

Symetis SA6 sites in 3 countries89 target enrollmentSeptember 2011

ConditionsSymptomatic Aortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Symptomatic Aortic Stenosis
Sponsor: Symetis SA
Enrollment: 89
Locations: 6
Primary Endpoint: Freedom from all-cause mortality
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts

Detailed Description

A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

August 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Symetis SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients 75 years of age and older
•Logistic EuroSCORE ≥ 20%
•Severe aortic stenosis characterized by mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or aortic valve area of \< 1.0 cm2
•New York Heart Association (NYHA) Functional Class \> II
•Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE)
•Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis
•Patient willing to participate in the study and provide signed informed consent

Exclusion Criteria

•Unicuspid or bicuspid aortic valve
•Extreme eccentricity of calcification
•Severe mitral regurgitation ( \>2+)
•Pre-existing prosthetic heart valve in any position and / or prosthetic ring
•Aortic or peripheral anatomy NOT appropriate for transfemoral implant
•Thoracic (TAA) or abdominal (AAA) aortic aneurysm
•Presence of endovascular stent graft for treatment of TAA or AAA
•TEE is contraindicated
•Left Ventricular Ejection Fraction (LVEF) \< 30% by echocardiography (ECHO)
•ECHO evidence of intracardiac mass, thrombus, or vegetation

Outcomes

Primary Outcomes

Freedom from all-cause mortality

Time Frame: 30-Day Follow-up

Rate of all-cause mortality

Secondary Outcomes

Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.(30-Days and 12 Months Follow-up)
Change in NYHA class over time(30-Day and 12-Month)
Procedural success during device implantation(intraoperative)
Device success(30-Day and 12-Month Follow-up)