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Trial record 1 of 1 for:    NCT04331769
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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

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ClinicalTrials.gov Identifier: NCT04331769
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ancora Heart, Inc.

Study Description
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Brief Summary:
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).

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

Detailed Description:

The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.

Subjects will be randomized in a 1:1 ratio:

  1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200)
  2. Control group: Guideline-directed medical therapy (GDMT) (n~200)
Study Design
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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 Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : June 21, 2024
Estimated Study Completion Date : December 21, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Device group: AccuCinch Ventricular Restoration System
Subjects in this arm will receive the AccuCinch Ventricular Restoration System
 Device: AccuCinch Ventricular Restoration System
AccuCinch Ventricular Restoration 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


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from device- or femoral artery access-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
    6. Acute kidney injury requiring renal replacement therapy

  2. Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score [ Time Frame: 180 days ]
    Higher scores in the KCCQ reflect better health status

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

  4. Freedom from device- or femoral artery access-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
    6. Acute kidney injury requiring renal replacement therapy

  5. A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) [ Time Frame: 365 days ]
    A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method


Secondary Outcome Measures :
  1. Number of all-cause deaths or all-cause hospitalizations [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  2. Number of all-cause deaths [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  3. Number of all-cause hospitalizations [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  4. Incidence of all serious adverse events, including device- and procedure- related complications [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  5. Changes from baseline in New York Heart Association (NYHA) functional class [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  6. Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) [ Time Frame: 30 days, 90 days, 365 days, 545 days, 730 days ]
    Higher scores in the KCCQ reflect better health status

  7. Changes from baseline in 6-Minute Walk Test (6MWT) [ Time Frame: 30 days, 90 days, 365 days, 545 days, 730 days ]
    Measure in meters

  8. Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo [ Time Frame: 30 days, 90 days, 365 days, 730 days ]
  9. Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT [ Time Frame: 180 days ]
  10. Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo [ Time Frame: 30 days, 90 days, 365 days, 730 days ]
  11. Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT [ Time Frame: 180 days ]
  12. Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo [ Time Frame: 30 days, 90 days, 365 days, 730 days ]
  13. Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT [ Time Frame: 180 days ]
  14. Rate and number of cardiovascular death events [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  15. Rate and number of heart failure death events [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
  16. Rate and number of heart failure-related hospitalizations [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]

Other Outcome Measures:
  1. Changes from baseline in mitral effective regurgitant orifice area (EROA) [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
  2. Changes from baseline in left atrial strain measured by Echo [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
  3. Changes from baseline in left ventricular global longitudinal strain measured by Echo [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
  4. Changes from baseline in right ventricular free wall longitudinal strain measured by Echo [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
  5. Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
    Higher scores in the KCCQ reflect better health status

  6. Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire [ Time Frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days ]
    Lower scores in the EQ-5D-5L reflect better health status

  7. Changes from baseline in right ventricular (RV) fractional area change measured by Echo [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
    Measured by percent change

  8. Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
    Measured in centimeters or millimeters

  9. Changes from baseline in tricuspid regurgitation measured by Echo [ Time Frame: 30 days, 90 days, 180 days, 365 days, 730 days ]
    Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL)


Eligibility Criteria
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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:

  1. Age 18-years or older
  2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
  3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab

  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. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.

    1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments
    2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change
    3. When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)
    4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
    5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change
    6. If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition
    7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
    8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)
    9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed > 90 days before the screening TTE and CT, and an ICD must be placed > 30 days before the screening TTE and CT
  7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required 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 90 days prior to consent
  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. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
  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-randomization (including therapeutic right heart procedures)
  8. Active bacterial endocarditis
  9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or 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 of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke

    Valvular

  12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
  13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
  14. Prior mitral or aortic valve replacement
  15. Tricuspid regurgitation grade 4+ (severe)
  16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)

  17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)

    Procedural

  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

    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
Contacts and Locations
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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): NCT04331769


Contacts
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Contact: Michael Zapien, MS, CCRA 408-727-1105 mzapien@ancoraheart.com

Locations
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Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
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Study Chair: Martin B Leon, MD Columbia University
Principal Investigator: Ulrich P Jorde, MD Montefiore Medical Center/Albert Einstein College of Medicine
Principal Investigator: Mark Reisman, MD New York Presbyterian/Weill Cornell Medicine
More Information
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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: December 27, 2021
Last Verified: December 2021
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
Keywords provided by Ancora Heart, Inc.:
Heart Failure
Reduced Ejection Fraction
Cardiomyopathy
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
 Cardiovascular Diseases
Cardiomegaly
Laminopathies
Genetic Diseases, Inborn