Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Mitral Regurgitation
- Sponsor
- Mardil Medical
- Enrollment
- 15
- Locations
- 12
- Primary Endpoint
- Evaluate SAE Rates
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.
Detailed Description
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who have been diagnosed with Grade 3-4 functional mitral valve regurgitation and deemed eligible per assessment by the inclusion/exclusion criteria. The duration of the study follow-up is 36 months from the time of therapy adjustment. Data from this trial may be utilized in support of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be performed at 1, 3, 6, 12, 24, and 36 months post-therapy adjustment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults ≥18 years of age
- •Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)
- •NYHA Class II to IV
- •Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
- •Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days
- •Subjects with a Class I indication for CRT implant according to current guidelines should have CRT implant prior to entry into the study. Subjects who have existing CRT implants may be included in the study if the implant has been in place for at least 90 days; reprogramming of an implanted CRT that results in increased biventricular pacing (from \<92% to ≥92%) must be in place for at least 30 days.
- •Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography
- •Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
- •Subject is willing and available to return for study follow-up
- •Subject or legal representative understands and provides signed informed consent for participation in study
Exclusion Criteria
- •Life expectancy of less than 12 months due to conditions other than cardiac status
- •Anticipated need for LVAD or transplant within 12 months
- •Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- •American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure
- •Six-minute walk distance \< 150 meters
- •Identified need for any cardiovascular surgery
- •STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee
- •Untreated clinically significant coronary artery disease
- •Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads, pericarditis, or other procedure involving pericardial access)
- •Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI myocardial infarction, unstable angina) or clinically significant cardiac events (e.g. hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any hospitalization) within 30 days of enrollment
Outcomes
Primary Outcomes
Evaluate SAE Rates
Time Frame: 1 Month
Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures
Time Frame: Intra-operative
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)
Secondary Outcomes
- Evaluate SAE Rates(36 Months)
- Evaluate MR Severity(36 Months)
- Evaluate Changes in Patient Symptoms by NYHA(36 Months)
- Evaluate Reverse Ventricular Remodeling(36 Months)
- Evaluate Changes in Patient Functional Status by Six-Minute Walk(36 Months)
- Evaluate Changes in Patient Functional Status by KCCQ(36 Months)