CorCinch-HF Repair System in Patients Who Present With Symptomatic Non-Ischemic or Ischemic Dilated Cardiomyopathy

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Brief Title

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Official Title

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Brief Summary

      This is a prospective, randomized, open-label, international, multi-center clinical study to
      evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients
      with heart failure and reduced ejection fraction (HFrEF).

Study Type


Primary Outcome

Freedom from device-related major adverse events (MAE)


Heart Failure With Reduced Ejection Fraction (HFrEF)


AccuCinch Ventricular Restoration System

Study Arms / Comparison Groups

 Device group: AccuCinch Ventricular Restoration System
Description:  Subjects in this arm will receive the AccuCinch Ventricular Restoration System


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 18, 2020

Completion Date

March 27, 2029

Primary Completion Date

January 27, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18-years or older

          2. Ejection Fraction: ≥20% and ≤40%

          3. LV end-diastolic diameter ≥55 mm

          4. Symptom Status:

               1. NYHA III,

               2. NYHA ambulatory IV, or

               3. NYHA II with a heart failure hospitalization within the prior 12 months (of
                  signing the consent)

          5. Able to complete six-minute walk test with distance between 100 m and 450 m.

          6. Treatment with guideline-directed medical and device-based therapies for heart
             failure. Medical treatments should have been established for at least 90 days prior to
             obtaining consent and doses of medications should be stable for at least 30 days prior
             to baseline screening, with "stable" defined as no more than 100% increase or 50%
             decrease of total daily doses. When applicable, device-based therapies should include:

               1. A CRT device, which is required for at least 90 days prior to baseline screening
                  in subjects with left bundle branch block pattern and QRS duration >/=150 ms

               2. An ICD, which is required for all patients in whom it is indicated (based on best
                  local clinical practice) for at least 30 days prior to baseline screening

          7. Able and willing to complete all qualifying diagnostic and functional tests and agrees
             to comply with study follow-up schedule

        Exclusion Criteria:


          1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular
             surgery, or carotid surgery within 90 days.

          2. Untreated clinically significant coronary artery disease (CAD) requiring

          3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile
             aortic atheroma, intracardiac mass, thrombus or vegetation

          4. Suboptimal ventricular anatomy or wall thickness as determined from baseline
             echocardiography and CT scan, with final determination made by the Eligibility

          5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy
             (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive
             cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)

          6. Hemodynamic instability within 30 days prior to the implant defined as subject
             requiring inotropic support or mechanical hemodynamic support

          7. Any planned cardiac surgery or interventions within the next 180 days post-implant
             (including therapeutic right heart procedures)

          8. Active bacterial endocarditis

          9. Severe RV dysfunction assessed by right heart catheterization (RHC) and TTE

         10. Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to
             vasodilator therapy

         11. History of any stroke within the prior 90 days or documented Modified Rankin Scale ≥ 2
             disability from any prior stroke


         12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)

         13. Untreated degenerative (primary) mitral valve disease

         14. Prior mitral or aortic valve replacement

         15. Severe (≥3+) tricuspid regurgitation

         16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or outflow velocity
             >300 cm/sec)

         17. Aortic regurgitation ≥2+


         18. Anatomical pathology or constraints preventing appropriate access/implant of the
             AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a
             20F Introducer sheath)

         19. Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)

         20. Subjects in whom anticoagulation during the procedure is contraindicated

         21. Subjects in whom 90 days of antiplatelet therapy is contraindicated

         22. Known allergy to nitinol, polyester, or polyethylene

         23. 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


         24. Life expectancy <1 year due to non-cardiac conditions

         25. Currently participating in another interventional investigational study

         26. Subjects on high dose steroids or immunosuppressant therapy

         27. Female subjects who are pregnant, of child-bearing potential without a documented
             birth control method, or who are lactating




18 Years - N/A

Accepts Healthy Volunteers



Martin B Leon, MD, 408-727-1105, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Ancora Heart, Inc.

Study Sponsor

Martin B Leon, MD, Study Chair, Columbia University

Verification Date

December 2020