NCT02744677 COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
| NCT ID | NCT02744677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Complex Congenital Heart Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2016-07-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2016-07-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Weight ≥ 20 kg (44 lbs.) 2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use 3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg. 4. The subject/subject'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: 1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics) 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days 3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder 4. Inappropriate anatomy for femoral introduction and delivery of the study valve 5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty 6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI) 7. Interventional/surgical procedures within 30 days prior to the TPVI procedure. 8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure. 9. History of or current intravenous drug use 10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year 11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated 13. Participating in another investigational drug or device study that has not reached its primary endpoint. 14. Female who is lactating or pregnant
Contact & Investigator
D. Scott Lim, MD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT02744677 clinical trial?
This trial is open to participants of all sexes, studying Complex Congenital Heart Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02744677 currently recruiting?
Yes, NCT02744677 is actively recruiting participants. Contact the research team at THV_CT.gov@Edwards.com for enrollment information.
Where is the NCT02744677 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Los Angeles, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT02744677 clinical trial?
NCT02744677 is sponsored by Edwards Lifesciences. The principal investigator is D. Scott Lim, MD at University of British Columbia. The trial plans to enroll 108 participants.