Trials / Unknown
UnknownNCT03163329
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- China National Center for Cardiovascular Diseases · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TAVR | Transcatheter Aortic Valve Replacement |
| PROCEDURE | SAVR | Surgical Aortic Valve Replacement |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2020-10-31
- Completion
- 2024-10-31
- First posted
- 2017-05-23
- Last updated
- 2018-01-11
Source: ClinicalTrials.gov record NCT03163329. Inclusion in this directory is not an endorsement.