Mitral Valve Insufficiency
Conditions
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.
Interventions
DEVICEHalf Moon TMVr System
The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.
Sponsors
Half Moon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 Days | Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Placement | 30 Days (+ annually through 5 years) | Assessment of the ability to accurately deliver and place the implant within the native anatomy |
| Device Performance | 30 Days (+ annually through 5 years) | The degree of improvement of MR grade |
| Symptom Improvement | 30 Days (+ annually through 5 years) | The degree of improvement of MR symptoms |
| Device Durability | 30 Days (+ annually through 5 years) | The durability of TMVr function |
Countries
United States
Contacts
Primary ContactCraig Straley
Backup ContactRomil Rambhia
Outcome results
None listed