Trials / Completed
CompletedNCT02987387
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
New Enrollment SAPIEN XT Post-Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 57 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
Detailed description
The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
Conditions
- Pulmonary Valve Insufficiency
- Pulmonary Valve Stenosis
- Heart Defects, Congenital
- Congenital Abnormalities
- Cardiovascular Diseases
- Heart Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN XT THV | SAPIEN XT THV will be implanted in the pulmonic position. |
Timeline
- Start date
- 2017-07-17
- Primary completion
- 2021-08-09
- Completion
- 2025-09-30
- First posted
- 2016-12-08
- Last updated
- 2025-12-15
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02987387. Inclusion in this directory is not an endorsement.