Trials / Active Not Recruiting
Active Not RecruitingNCT03517436
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Detailed description
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TAVR with CENTERA THV | TAVR with the Edwards CENTERA THV System |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2020-10-02
- Completion
- 2030-07-01
- First posted
- 2018-05-07
- Last updated
- 2025-11-13
- Results posted
- 2021-09-30
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03517436. Inclusion in this directory is not an endorsement.