RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation

Quick Facts

Study Start:2020-12-08

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04343313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 95 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Craig Straley

CONTACT

4153109197

craigstraley.halfmoon@gmail.com

Romil Rambhia

CONTACT

rrambhia@thefoundry.com

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10467

United States

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, 10032

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

UPMC Heart & Vascular Institute

Harrisburg, Pennsylvania, 17104

United States

Collaborators and Investigators

Sponsor: Half Moon Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-08

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2020-12-08

Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

Mitral Valve Insufficiency