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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533517
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ancora Heart, Inc.

Brief Summary:
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

Condition or disease Intervention/treatment Phase
Heart Failure Cardiomyopathy, Dilated Device: AccuCinch® Ventricular Repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Early Feasibility Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: AccuCinch® Ventricular Repair System Device: AccuCinch® Ventricular Repair
AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)




Primary Outcome Measures :
  1. Safety measured by device-related or procedure-related major adverse events (MAEs) [ Time Frame: 30-day ]
    Device-related or procedure-related major adverse events (MAEs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533517


Contacts
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Contact: Michael Zapien, MS, CCRA 4087271105 mzapien@ancoraheart.com
Contact: Judit Adorjan 4087271105 jadorjan@ancoraheart.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
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Study Director: Michael Zapien, MS, CCRA Ancora Heart, Inc.
Principal Investigator: Ulrich Jorde, MD Montefiore Medical Center
Principal Investigator: Azeem Latib, MD Montefiore Medical Center
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Responsible Party: Ancora Heart, Inc.
ClinicalTrials.gov Identifier: NCT03533517    
Other Study ID Numbers: 5017
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly