Cardiomyopathy, Dilated, Heart Failure
Conditions
Brief summary
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
Detailed description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.
Interventions
DEVICEAccuCinch® Ventricular Restoration
AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
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 * Ejection Fraction: ≥20 and ≤40% * LV end-diastolic diameter ≥55 mm * Symptom Status: NYHA III-IV (i.e., ambulatory) * Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses. * Patients with left bundle branch block pattern and QRS duration \>150ms are required to have a CRT device for at least 3 months * Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment * Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Exclusion criteria
* Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months * Mitral regurgitation grade 3 (moderate-severe) or more * 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) * Significant RV dysfunction (TAPSE \< 14) * Severe tricuspid regurgitation * 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 or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair 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 * History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke * Subjects in whom anticoagulation or antiplatelet therapy is contraindicated * Known allergy to nitinol, polyester, or polyethylene * Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure. * Life expectancy \< 1 year due to non-cardiac conditions * Currently participating in another interventional investigational study * Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month * Subjects on high dose steroids or immunosuppressant therapy * Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by device-related or procedure-related major adverse events (MAEs) | 30-day | Device-related or procedure-related major adverse events (MAEs) |
Countries
United States
Outcome results
None listed