COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
New Enrollment SAPIEN XT Post-Approval Study
1 other identifier
observational
57
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Start
First participant enrolled
July 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedDecember 15, 2025
September 1, 2025
4.1 years
October 19, 2016
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from device- or procedure-related death or reintervention
1 year
Secondary Outcomes (3)
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
1 year
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions
1 year
Device Success
48 Hours Prior to Discharge
Study Arms (1)
TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV
Interventions
Eligibility Criteria
Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.
You may qualify if:
- Patient has a dysfunctional, non-compliant RVOT conduit.
- 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.
You may not qualify if:
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Alabama
Birmingham, Alabama, 35294, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Advocate Children's Hospital
Oak Lawn, Illinois, 60453, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Children's Heart Center Nevada
Las Vegas, Nevada, 89109, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2016
First Posted
December 8, 2016
Study Start
July 17, 2017
Primary Completion
August 9, 2021
Study Completion
September 30, 2025
Last Updated
December 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share