Trials / Completed
CompletedNCT03222128
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for Intermediate Risk Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,074 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
Detailed description
This study design consists of PIIS3i cohort. The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access. To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TAVR | Implantation of the SAPIEN 3 |
Timeline
- Start date
- 2014-02-17
- Primary completion
- 2015-11-18
- Completion
- 2024-10-09
- First posted
- 2017-07-19
- Last updated
- 2025-01-03
- Results posted
- 2018-08-14
Locations
51 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03222128. Inclusion in this directory is not an endorsement.