The ENCIRCLE Trial

Launched by EDWARDS LIFESCIENCES · Nov 5, 2019

Keywords

ClinConnect Summary

The ENCIRCLE Trial is a study looking at the safety and effectiveness of a device called the SAPIEN M3 System for patients who have a serious heart condition known as mitral regurgitation (MR), which means the heart's mitral valve isn't working properly. This trial is specifically for individuals who are experiencing symptoms and have at least moderate MR (rated 3+), but for whom other treatment options, like surgery, are not suitable due to various medical reasons.

To be eligible for the trial, participants need to be at least 18 years old and have their heart failure symptoms managed well for at least 30 days before joining. They should also have a heart condition that makes traditional treatments unsafe or impractical. If someone joins the study, they can expect to receive care and follow-up during the trial. This study is currently recruiting participants, and it’s important for anyone considering joining to discuss it with their healthcare provider to understand the potential benefits and risks involved.

Gender

ALL

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