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New treatment option for Mitral Valve Insufficiency
Official title The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
ClinicalTrials.gov ID: NCT04343313
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 95
You may be able to join 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...
- Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved...
- Age ≥ 21
- Native mitral valve geometry and size compatible with the Half Moon TMVr implant
You likely can't join 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...
- 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) \ 120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure
See the full eligibility criteria
- 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 Key
- 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) \ 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 treatment 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
- Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc
- Need for emergent surgery
- Endocarditis within 6 months
- Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment
- GI bleeding within 6 months
- History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion
- Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
- Platelet count of \<75,000 cells/mm3
- Renal insufficiency (Creatinine \> 2.5 mg/dL)
- Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
- Contraindication to transesophageal echocardiography (TEE)
- Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
- Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
- Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Harrisburg, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; The Bronx, New York, United States; Cleveland, Ohio, United States; Portland, Oregon, United States; Harrisburg, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.