Trials / Active Not Recruiting
Active Not RecruitingNCT02675114
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
Detailed description
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality \< 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years. A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SAVR | SAVR with a commercially available bioprosthetic valve. |
| DEVICE | SAPIEN 3 THV | TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2020-11-16
- Completion
- 2029-12-01
- First posted
- 2016-02-05
- Last updated
- 2026-01-14
- Results posted
- 2021-12-02
Locations
77 sites across 5 countries: United States, Australia, Canada, Japan, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02675114. Inclusion in this directory is not an endorsement.