| NCT ID | NCT04153292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2020-11-12 |
| Primary Completion | 2027-02-28 |
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 900 participants in total. It began in 2020-11-12 with a primary completion date of 2027-02-28.
⚠ 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 establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. MR ≥ 3+ 3. NYHA functional class ≥ II 4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations. 5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment. 6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve 2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve 3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation 4. Left ventricular ejection fraction \<25% 5. Severe right ventricular dysfunction 6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months 7. History of heart transplant 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Active bacterial endocarditis within 180 days of the procedure 10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure 11. Myocardial infarction within 30 days of the procedure 12. Clinically significant untreated coronary artery disease requiring revascularization 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure 14. Stroke or transient ischemic attack within 90 days of the procedure 15. Irreversible, severe pulmonary hypertension 16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use 17. Renal insufficiency or receiving renal replacement therapy 18. Liver disease 19. Planned surgery within the next 12 months 20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure 21. Active infection requiring current antibiotic therapy 22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 24. Refusal of blood products 25. Female who is pregnant or lactating 26. Estimated life expectancy \<12 months due to non-cardiac conditions 27. Participating in another investigational drug or device study that has not reached its primary endpoint 28. Subject considered to be part of a vulnerable population
Contact & Investigator
John Webb, MD
PRINCIPAL INVESTIGATOR
St. Paul's Hospital
Frequently Asked Questions
Who can join the NCT04153292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04153292 currently recruiting?
Yes, NCT04153292 is actively recruiting participants. Contact the research team at TMTT_Clinical@edwards.com for enrollment information.
Where is the NCT04153292 trial being conducted?
This trial is being conducted at Huntsville, United States, Phoenix, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT04153292 clinical trial?
NCT04153292 is sponsored by Edwards Lifesciences. The principal investigator is John Webb, MD at St. Paul's Hospital. The trial plans to enroll 900 participants.