NCT04343313 The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
| NCT ID | NCT04343313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Half Moon Medical |
| Condition | Mitral Valve Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-12-08 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 30 participants in total. It began in 2020-12-08 with a primary completion date of 2024-12-31.
⚠ 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
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04343313 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 95 Years, studying Mitral Valve Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04343313 currently recruiting?
Yes, NCT04343313 is actively recruiting participants. Contact the research team at craigstraley.halfmoon@gmail.com for enrollment information.
Where is the NCT04343313 trial being conducted?
This trial is being conducted at New York, United States, The Bronx, United States, Cleveland, United States, Portland, United States and 1 additional location.
Who is sponsoring the NCT04343313 clinical trial?
NCT04343313 is sponsored by Half Moon Medical. The trial plans to enroll 30 participants.