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

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: NCT04331769
Recruitment Status : Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ancora Heart, Inc.

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).

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction (HFrEF) Dilated Cardiomyopathy Device: AccuCinch Ventricular Repair System Drug: Guideline-Directed Medical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 27, 2021
Estimated Primary Completion Date : January 27, 2025
Estimated Study Completion Date : March 27, 2029


Arm Intervention/treatment
Experimental: Device group: AccuCinch Ventricular Repair System
Subjects in this arm will receive the AccuCinch Ventricular Repair System
Device: AccuCinch Ventricular Repair System
AccuCinch Ventricular Repair System

Active Comparator: Control group: Guideline-Directed Medical Therapy
Subjects in this arm will receive guideline-directed medical therapy (GDMT)
Drug: Guideline-Directed Medical Therapy
Guideline-Directed Medical Therapy




Primary Outcome Measures :
  1. Freedom from device-related major adverse events (MAE) [ Time Frame: 180 days ]

    MAE defined as:

    1. All-cause death,
    2. Myocardial infarction,
    3. Stroke,
    4. Need for non-elective cardiovascular surgery,
    5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours

  2. Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score [ Time Frame: 180 days ]
    Change in KCCQ Score from baseline

  3. 6-Minute Walk Test (6MWT) distance (m) [ Time Frame: 180 days ]
    Change in 6MWT distance (m) from baseline

  4. Freedom from device-related major adverse events (MAE) [ Time Frame: 365 days ]

    MAE defined as:

    1. All-cause death,
    2. Myocardial infarction,
    3. Stroke,
    4. Need for non-elective cardiovascular surgery,
    5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours

  5. A hierarchical composite endpoint, evaluated using the Finkelstein-Shoenfeld Rank Test method: [ Time Frame: 365 days ]

    Composite defined as:

    1. All-cause death,
    2. LVAD implant or heart transplant,
    3. Number of heart failure hospitalizations, and
    4. Change from baseline KCCQ score



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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:

  • 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:

Cardiovascular

  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 revascularization
  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

    Valvular

  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+

    Procedural

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

    General

  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
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Responsible Party: Ancora Heart, Inc.
ClinicalTrials.gov Identifier: NCT04331769    
Other Study ID Numbers: 5019
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly