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

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

Overview

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

• Device Half 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.

Primary outcome measures

• Adverse Events [Time frame: 30 Days]

Secondary outcome measures (4)

• Device Placement [Time frame: 30 Days (+ annually through 5 years)]
• Device Performance [Time frame: 30 Days (+ annually through 5 years)]
• Symptom Improvement [Time frame: 30 Days (+ annually through 5 years)]
• Device Durability [Time frame: 30 Days (+ annually through 5 years)]

Eligibility criteria

Inclusion 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 5 centers

• Columbia University Medical Center/NewYork Presbyterian Hospital — New York
• Montefiore Medical Center — The Bronx
• University Hospitals Cleveland Medical Center — Cleveland
• Oregon Health & Science University — Portland
• UPMC Heart & Vascular Institute — Harrisburg

Identifiers

NCT: NCT04343313 · CIP-0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗