The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

Launched by HALF MOON MEDICAL · Apr 10, 2020

Keywords

ClinConnect Summary

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study is a clinical trial designed to test a new device called the Half Moon TMVr System. This trial is focused on helping patients who have a serious heart condition known as mitral valve insufficiency, which means the heart's mitral valve is not closing properly. This can lead to symptoms like shortness of breath or fatigue, especially when patients are active. The study is specifically looking for patients who are at high risk for traditional surgery and who continue to have symptoms despite taking their medications.

To participate in this study, patients need to be at least 21 years old and have moderate to severe mitral regurgitation, which is graded as 3+ or higher. They should also be experiencing symptoms and unable to have conventional surgery due to their health conditions. Participants will receive the new device and will be monitored closely after the procedure to see how well it works and if it is safe. It’s important for potential participants to know that they will need to commit to follow-up visits and sign a consent form to be part of the study.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)
• • 2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team
• • 3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies
• • 4. Age ≥ 21
• • 5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant
• • 6. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
• • 7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits
• Key Exclusion Criteria:
• • 1. Prior transseptal intervention with occlusion device currently implanted
• • 2. Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system
• • 3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
• • 4. Prohibitive mitral annular or leaflet calcification
• • 5. Diseased mitral anterior leaflet such as flail or prolapse
• • 6. Left ventricular ejection fraction (LVEF) \< 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) \>120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure
• • 7. Left ventricular end diastolic diameter (LVEDD) \> 75mm
• • 8. Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure
• • 9. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
• • 10. Severe tricuspid regurgitation
• • 11. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
• • 12. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
• • 13. Prior stroke, TIA, or myocardial infarction within 90 days
• • 14. Need for coronary revascularization
• • 15. Severe symptomatic carotid artery stenosis
• • 16. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc
• • 17. Need for emergent surgery
• • 18. Endocarditis within 6 months
• • 19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment
• • 20. GI bleeding within 6 months
• • 21. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion
• • 22. Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
• • 23. Platelet count of \<75,000 cells/mm3
• • 24. Renal insufficiency (Creatinine \> 2.5 mg/dL)
• • 25. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
• • 26. Contraindication to transesophageal echocardiography (TEE)
• • 27. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
• • 28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
• • 29. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint