Patient case: 32-year-old male with dilated cardiomyopathy; genetic feature: LMNA

Clinical trial: Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

Summary: This is an international multi-center, non-randomized, prospective safety and performance study to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Subjects who present with heart failure with or without functional mitral regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology
  1. For subjects with FMR, severity of FMR: ≥ Moderate 2+
  2. For subjects without FMR, LVEDD ≥ 55 mm
  -  Ejection Fraction: ≥20 to ≤60%
  -  Symptom Status: NYHA II-IVa
  -  Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 30 days
  -  Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team) High risk for mitral valve surgery is defined utilizing established risk scores (STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC (frailty index; major organ system compromise not to be improved postoperatively; procedure specific impediments) (MVARC Part 1)
  -  Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
  -  Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
  Exclusion Criteria:
  -  Life expectancy <1 yr due to noncardiac conditions
  -  NYHA functional class IVb or ACC/AHA stage D heart failure
  -  Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
  -  Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology
  -  Fixed pulmonary artery systolic pressure >70 mm Hg
  -  Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
  -  Mitral valve anatomy which may preclude proper device treatment
  -  Mitral valve area <4.0 cm2 (if new device therapy may further decrease the mitral orifice area)
  -  Any prior mitral valve surgery or transcatheter mitral valve procedure
  -  Stroke or transient ischemic event within 30 days
  -  Modified Rankin Scale ≥ 4 disability
  -  Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  -  Untreated clinically significant coronary artery disease requiring revascularization
  -  Severe symptomatic carotid stenosis (>70% by ultrasound).
  -  Myocardial infarction ≤ 30 days
  -  Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  -  Tricuspid valve disease requiring surgery or severe tricuspid regurgitation (per ASE guidelines; core lab assessment)
  -  Aortic valve disease requiring surgery
  -  Moderate or severe aortic valve stenosis or regurgitation
  -  Aortic valve prosthesis
  -  Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus, or vegetation
  -  Need for any cardiovascular surgery (other than for MV disease)
  -  Active endocarditis
  -  Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch System (e.g., femoral arteries will not support an 18F system)
  -  Known allergy to nickel, polyester, or polyethylene
  -  Active infections requiring current antibiotic therapy
  -  Currently participating in another interventional investigational study
  -  Subjects in whom transesophageal echocardiography is contraindicated or high risk
  -  Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month
  -  Absence of CRT with Class I indication criteria for biventricular pacing
  -  Subjects on high dose steroids or immunosuppressant therapy
  -  Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits
  -  Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
  -  Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception

Relevance to patient case: not relevant