Trials / Completed
CompletedNCT03752996
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Symetis SA · Industry
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ACURATE TF™ Aortic Valve System | Transcatheter Aortic Valve Implantation |
Timeline
- Start date
- 2012-05-09
- Primary completion
- 2017-06-30
- Completion
- 2022-03-30
- First posted
- 2018-11-26
- Last updated
- 2023-02-23
Locations
5 sites across 2 countries: Brazil, Germany
Source: ClinicalTrials.gov record NCT03752996. Inclusion in this directory is not an endorsement.