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Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (CorCinch-HFrEF)

A

Ancora Heart

Status

Active, not recruiting

Conditions

Cardiomyopathy, Dilated
Heart Failure

Treatments

Device: AccuCinch® Ventricular Restoration

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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).

Full description

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

AccuCinch® Ventricular Restoration System
Experimental group
Treatment:
Device: AccuCinch® Ventricular Restoration

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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