EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation

Launched by POLARES MEDICAL SA · Dec 21, 2020

Keywords

ClinConnect Summary

The EXPLORE FMR trial is an early study looking at a new device called the PLAR Implant and Delivery System, which aims to help treat a heart condition known as functional mitral regurgitation. This condition occurs when the heart’s mitral valve doesn’t close properly, causing blood to flow backward into the heart. The study will involve up to 10 patients at a single center in Brazil and focuses on understanding how safe and effective this new treatment is. Participants will be followed for up to five years to gather important information that can guide future treatments for this condition.

To be eligible for this study, participants must be at least 18 years old and suffer from severe functional mitral regurgitation. They should have a specific score that indicates they are at high risk for traditional surgery but are still operable. Additionally, they need to be in a certain stage of heart failure and must agree to attend all follow-up visits after the procedure. It’s important to note that there are several health conditions that would exclude someone from participating, such as severe issues with other heart valves, recent heart surgeries, or certain complications like infections. This trial is not yet recruiting, so interested patients should keep an eye out for updates on when they can apply.

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Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years of age or older
• • 2. Greater than moderate functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
• • 3. Patient must present with an STS Score less than 10%
• • 4. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
• • 5. New York Heart Association (NYHA) Functional Class III or IV
• • 6. Patient willing to participate in study and provide signed IRB/EC-approved informed consent
• • 7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
• Exclusion Criteria:
• • 1. Severe tricuspid regurgitation
• • 2. Severe aortic stenosis or insufficiency
• • 3. Severe mitral annulus calcification
• • 4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
• • 5. Implanted vena cava filter
• • 6. Femoral veins with severe angulation and calcification
• • 7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan
• • 8. Active infection or endocarditis
• • 9. Previous mitral valve surgery
• • 10. Prior orthotopic heart transplantation
• • 11. Pulmonary artery systolic hypertension \> 70mmHg
• • 12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
• • 13. Left ventricular ejection fraction (LVEF) \< 30%
• • 14. Implant or revision of any pacing device \< 30 days prior to intervention
• • 15. Symptomatic coronary artery disease treated \< 30 days prior to study procedure
• • 16. Myocardial infarction requiring intervention \< 30 days prior to study procedure
• • 17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
• • 18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to study procedure
• • 19. Stroke \< 180 days prior to study procedure
• • 20. Severe renal insufficiency (creatinine \> 3.0 mg/dL) or patient requiring dialysis
• • 21. Cardiogenic shock at time of enrolment
• • 22. Hemodynamic instability requiring inotropic support or mechanical heart assistance
• • 23. Concurrent medical condition with a life expectancy of less than 2 years
• • 24. Pregnancy at time of enrolment
• • 25. History of bleeding diathesis or coagulopathy or leukopenia (WBC \< 3,000 mcL) or acute anemia (Hb \< 9 g/dL) or thrombocytopenia (platelets \< 50,000 cells mcL)
• • 26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
• • 27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
• • 28. Emergency situations
• • 29. Company employees or their immediate family members
• • 30. Patient is under guardianship
• • 31. Patient is participating in another clinical study for which follow-up is currently ongoing