Actively Recruiting
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
Led by Half Moon Medical · Updated on 2024-01-12
30
Participants Needed
5
Research Sites
472 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderately severe or severe mitral regurgitation (MR Grade �3 3+)
- Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy determined by the local multidisciplinary heart team
- Deemed high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies by the local heart team
- Age 21 years or older
- 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 and attend all required post-procedure follow-up visits
You will not qualify if you...
- Prior transseptal intervention with occlusion device currently implanted
- Implanted venous stents (iliac and femoral) including inferior vena cava filter or congenital IVC abnormalities precluding transfemoral access
- Presence 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 less than 25%, or 25-30% with left ventricular end diastolic volume index over 120 mL/m2 by resting echocardiogram within 30 days
- Left ventricular end diastolic diameter over 75 mm
- Pulmonary hypertension with resting pulmonary artery systolic pressures 2/3 or more of systemic systolic pressure
- Severe right ventricular dysfunction with right-sided congestive heart failure
- Severe tricuspid regurgitation
- Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
- Any endovascular or surgical procedure within 30 days before enrollment
- Prior stroke, transient ischemic attack, or heart attack within 90 days
- Need for coronary revascularization
- Severe symptomatic carotid artery stenosis
- Severe chronic obstructive pulmonary disease with forced expiratory volume less than 750 cc
- Need for emergency surgery
- Endocarditis within 6 months
- Unwilling or unable to follow anticoagulation treatment protocol
- Gastrointestinal bleeding within 6 months
- History of bleeding disorder or refusal of blood transfusion
- Hemodynamic instability requiring inotropic agents or mechanical circulatory support
- Platelet count less than 75,000 cells/mm3
- Renal insufficiency with creatinine over 2.5 mg/dL
- Active infections requiring antibiotics (may enroll 2 weeks after finishing antibiotics for temporary illness)
- Contraindication to transesophageal echocardiography
- Known allergy or contraindication to study or procedure medications/contrast not manageable medically
- Pregnant, nursing, or planning pregnancy (females must have negative pregnancy test before enrollment)
- Currently in another investigational drug or device study that has not reached its primary endpoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
3
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
4
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
5
UPMC Heart & Vascular Institute
Harrisburg, Pennsylvania, United States, 17104
Actively Recruiting
Research Team
C
Craig Straley
CONTACT
R
Romil Rambhia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here