COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
Purpose
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.
Conditions
- Pulmonary Valve Insufficiency
- Pulmonary Valve Stenosis
- Heart Defects, Congenital
- Congenital Abnormalities
- Cardiovascular Diseases
- Heart Diseases
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient has a dysfunctional, non-compliant RVOT conduit. 2. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria
- Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| TPVI | Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV |
|
Recruiting Locations
More Details
- NCT ID
- NCT02987387
- Status
- Active, not recruiting
- Sponsor
- Edwards Lifesciences
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.