Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
NCT02744677 · View on ClinicalTrials.gov ↗
Study Summary
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
Conditions Studied
Interventions
- DEVICE SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
- DEVICE SAPIEN 3 THV
- DEVICE SAPIEN 3 Ultra RESILIA THV
Study Locations (20)
Ohio
- The Lindner Research Center at Christ Hospital — Cincinnati
- Cincinnati Children's Hospital — Cincinnati
- Nationwide Children's Hospital — Columbus
California
- University of California, Los Angeles — Los Angeles
- University of California,, San Francisco (UCSF) — San Francisco
Massachusetts
- Massachusetts General Hospital — Boston
- Boston Children's Hospital — Boston
Missouri
- St. Louis Children's Hospital — St Louis
- Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital — St Louis
Pennsylvania
- Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia — Philadelphia
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Childrens Hospital of Colorado — Aurora
Georgia
- Emory University/Children's Healthcare of Atlanta — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2016-07-05 |
| Est. Completion | 2031-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02744677
The ClinicalTrials.gov registry entry for NCT02744677 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Complex Congenital Heart Defect appearing as the primary indexed condition, and to 3 interventions — of which SAPIEN 3/SAPIEN 3 Ultra RESILIA THV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02744677 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Ohio, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02744677 about?
NCT02744677 is a clinical study titled "COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction". This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a c...
What is the current status of trial NCT02744677?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2016-07-05. Estimated completion is 2031-06.
What conditions does trial NCT02744677 study?
This clinical trial studies the following conditions: Complex Congenital Heart Defect, Pulmonary Valve Insufficiency, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02744677?
The interventions under investigation include: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (DEVICE), SAPIEN 3 THV (DEVICE), SAPIEN 3 Ultra RESILIA THV (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02744677?
This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02744677 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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