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Clinical Trials/NCT03752996
NCT03752996
Completed
Not Applicable

ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis

Symetis SA5 sites in 2 countries140 target enrollmentMay 9, 2012
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ConditionsAortic Stenosis Symptomatic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Stenosis Symptomatic
Sponsor
Symetis SA
Enrollment
140
Locations
5
Primary Endpoint
Freedom from all-cause mortality
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.

Detailed Description

A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up 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.

Registry
clinicaltrials.gov
Start Date
May 9, 2012
End Date
March 30, 2022
Last Updated
3 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 \< 1.0 cm2
  • •New York Heart Association (NYHA) Functional Class \> II
  • •Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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
  • •Trans-esophageal echocardiogram (TEE) is contraindicated
  • •Left Ventricle 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-Days

Rate of all-cause mortality

Secondary Outcomes

  • Rate of MACCE (major cardiac and cerebrovascular event)(30-Days and 12-Months)

Study Sites (5)

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