Trials / Completed
CompletedNCT02687035
PARTNER II Trial: S3iCAP
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,822 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
Detailed description
This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN S3 valve | Transcatheter aortic valve replacement |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2017-10-01
- Completion
- 2018-12-01
- First posted
- 2016-02-22
- Last updated
- 2021-04-08
- Results posted
- 2021-04-08
Locations
56 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02687035. Inclusion in this directory is not an endorsement.