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

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Brief Title

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

Official Title

Randomized Clinical Evaluation of the AccuCinch® Ventricular Repair System in Patients Who Present With Symptomatic Non-Ischemic or Ischemic Dilated Cardiomyopathy: The CORCINCH-HF Study

Brief Summary

      This is a prospective, randomized, open-label, international, multi-center clinical study to
      valuate the safety and efficacy of the AccuCinch Ventricular Repair 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 Repair System

Study Arms / Comparison Groups

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

January 27, 2021

Completion Date

March 27, 2029

Primary Completion Date

January 27, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18-years or older

          -  Ejection Fraction: ≥20% and ≤40%

          -  LV end-diastolic diameter ≥55 mm

          -  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)

          -  Treatment with guideline-directed medical and device-based therapies for heart failure
             for at least 3 months with medical therapy doses stable for 1 month, stable being
             defined as no more than 100% increase or 50% decrease of total daily doses.
             Device-based therapies defined as:

               1. Patients with left bundle branch block pattern and QRS duration >150ms are
                  required to have a CRT device for at least 3 months, unless otherwise not
                  indicated, prior to randomization

               2. Patients required to have an ICD are required to have ICD implant at least 1
                  month prior to randomization

          -  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 3 months

          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. Wall thickness at the implantation zone <4 mm over a continuous section >10 mm in
             length, measured by contrast CT at end diastole. Implantation zone is defined as the
             basal free wall 5 - 20 mm below the MV plane

          5. Aberrant left ventricular morphology

          6. Hypertrophic cardiomyopathy, amyloid 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

          7. Hemodynamic instability within 30 days defined as, hypotension requiring inotropic
             support or mechanical hemodynamic support

          8. Any planned cardiac surgery or interventions within the next 6 months (including right
             heart procedures)

          9. Active bacterial endocarditis

         10. Severe RV dysfunction

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

         12. History of any stroke within the prior 3 months or documented Modified Rankin Scale ≥
             4 disability from any prior stroke


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

         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 Repair System (e.g., femoral arteries will not support a 20F

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

         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



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Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Ancora Heart, Inc.

Study Sponsor

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Verification Date

April 2020