Evaluating a new device for repairing the mitral valve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the safety and performance of the Half Moon Transcatheter Mitral Valve Repair (TMVr) System in patients suffering from severe, symptomatic mitral regurgitation who are at high risk for traditional surgery. It is a prospective, multi-center, single-arm, non-randomized early feasibility study. Participants will be monitored for their response to the device and any potential complications following the procedure. The study will include patients who have not responded adequately to medical therapy and are deemed unsuitable for existing transcatheter options.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Medical Center/NewYork Presbyterian Hospital
  New York, New York, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Recruiting
• UPMC Heart & Vascular Institute
  Harrisburg, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Craig Straley
• Email: craigstraley.halfmoon@gmail.com
• Phone: 4153109197

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Korea VHD Echo Study: Real-World Practice of Aortic, Mitral, and Tricuspid Valves

  This study looks at how valvular heart disease is managed in Korea by reviewing echocardiograms and medical records from multiple centers to see patterns in disease progression and treatment.

  Recruiting at 2 sites Yonsei University · Seoul, Seoul and 1 other locations · NCT07068633

• Evaluating the MITRIS RESILIA Mitral Valve in Asian Patients

  This study is testing how safe and effective the MITRIS RESILIA mitral valve is for Asian patients who are having surgery to replace their mitral valve.

  Recruiting Asan Medical Center · Seoul, SONGPA-GU · NCT06757049

• Investigating multiple and mixed heart valve diseases

  This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

• DragonFly EU Pivotal: Transcatheter mitral valve repair for mitral regurgitation

  This trial tests the DragonFly transcatheter mitral valve repair system in adults with symptomatic moderate-to-severe or severe degenerative or functional mitral regurgitation who are high surgical risk or remain symptomatic after treatment.

  Recruiting Hangzhou Valgen Medtech Co., Ltd · Bonn · NCT05927441

• Observational registry for patients treated with the NeoChord Artificial Chordae System

  This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.

  Recruiting at 5 sites NeoChord · Bonn and 4 other locations · NCT04190602

• Evaluating imaging parameters in patients with mitral valve insufficiency due to prolapse

  This study is testing how different imaging techniques can help doctors better understand and treat patients with mitral valve problems caused by prolapse.

  Recruiting Lille Catholic University · Lomme, Nord · NCT03962023

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.