COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Launched by EDWARDS LIFESCIENCES · Apr 15, 2016

Keywords

ClinConnect Summary

The COMPASSION S3 clinical trial is studying a new heart valve called the SAPIEN 3, designed to help patients with problems related to the pulmonary valve, which is important for blood flow from the heart to the lungs. This trial aims to determine how safe and effective this valve is for people who have a faulty right ventricular outflow tract (RVOT) conduit or valve. If you or a loved one has a complex congenital heart defect and is experiencing significant issues with their pulmonary valve, this study may provide a new treatment option.

To participate, candidates must weigh at least 20 kg (about 44 lbs.) and have specific heart conditions that indicate they need intervention. Participants will need to give informed consent, meaning they understand the study and agree to take part. Throughout the trial, participants can expect close monitoring and care from the medical team, as well as opportunities to contribute to important research that could improve treatments for others with similar heart issues. However, certain medical conditions or recent treatments may prevent someone from being eligible, so it’s essential to discuss this with a healthcare provider.

Gender

ALL

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