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ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)

NCT03752996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis Symptomatic

Interventions

DEVICE

ACURATE TF™ Aortic Valve System

Transcatheter Aortic Valve Implantation

Sponsors & Collaborators

  • Symetis SA

    lead INDUSTRY

Principal Investigators

  • Won Keun Kim, Dr. Med. · Kerckhoff Klinik Bad Nauheim, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-09
Primary Completion
2017-06-30
Completion
2022-03-30

Countries

  • Brazil
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752996 on ClinicalTrials.gov