The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation
1 other identifier
interventional
30
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedJanuary 12, 2024
January 1, 2024
4.1 years
April 9, 2020
January 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
30 Days
Secondary Outcomes (4)
Device Placement
30 Days (+ annually through 5 years)
Device Performance
30 Days (+ annually through 5 years)
Symptom Improvement
30 Days (+ annually through 5 years)
Device Durability
30 Days (+ annually through 5 years)
Study Arms (1)
Half Moon TMVr System
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)
- Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team
- 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
- Age ≥ 21
- Native mitral valve geometry and size compatible with the Half Moon TMVr implant
- Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
- Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits
You may not qualify if:
- Prior transseptal intervention with occlusion device currently implanted
- 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
- Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
- Prohibitive mitral annular or leaflet calcification
- Diseased mitral anterior leaflet such as flail or prolapse
- 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
- Left ventricular end diastolic diameter (LVEDD) \> 75mm
- Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure
- Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
- Severe tricuspid regurgitation
- Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
- Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
- Prior stroke, TIA, or myocardial infarction within 90 days
- Need for coronary revascularization
- Severe symptomatic carotid artery stenosis
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 13, 2020
Study Start
December 8, 2020
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2029
Last Updated
January 12, 2024
Record last verified: 2024-01