Cardiomyopathies, Heart Failure, Mitral Valve Insufficiency
Conditions
Brief summary
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy
Detailed description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020
Interventions
DEVICEMitral valve repair
Sponsors
Ancora Heart, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study patient is at least 18-years old * Severity of FMR: ≥ Moderate (i.e., 2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10) * Ejection Fraction: ≥20 to ≤60% * Symptom Status: NYHA II-IV (i.e., ambulatory) * Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month * Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team) * Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Exclusion criteria
* Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets) * Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days * Prior surgical, transcatheter, or percutaneous mitral valve intervention * Untreated clinically significant coronary artery disease (CAD) requiring revascularization * Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support * Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures) * NYHA class IV (i.e., non-ambulatory) or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D heart failure * Fixed pulmonary artery systolic pressure \>70 mmHg * Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab) * Modified Rankin Scale ≥ 4 disability * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology. * Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration System (e.g., femoral arteries will not support a 20F system) * Renal insufficiency (i.e., eGFR of \<30ml/min/1.73m2; Stage 4 or 5 CKD) * Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis * Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation * Active bacterial endocarditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Safety | 30-day | Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs). MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization. |
Countries
United States
Outcome results
None listed