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

Not Applicable

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF); Dilated Cardiomyopathy
• Interventions: Device: AccuCinch Ventricular Restoration System; Drug: Guideline-Directed Medical Therapy

• Registration Number: NCT04331769
• Lead Sponsor: Ancora Heart, Inc.

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).

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 Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-12-21
• Status Verified: 2024-10
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-08
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Device group: AccuCinch Ventricular Restoration System	AccuCinch Ventricular Restoration System	Subjects in this arm will receive the AccuCinch Ventricular Restoration System
Control group: Guideline-Directed Medical Therapy	Guideline-Directed Medical Therapy	Subjects in this arm will receive guideline-directed medical therapy (GDMT)

Primary Outcome Measures

Name	Time	Method
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score	180 days	Higher scores in the KCCQ reflect better health status
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)	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
Freedom from device- or femoral artery access-related major adverse events (MAE)	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
6-Minute Walk Test (6MWT) distance (m)	180 days	Change in 6MWT distance (m) from baseline

Secondary Outcome Measures

Name	Time	Method
Number of all-cause deaths	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT	180 days
Number of all-cause hospitalizations	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in 6-Minute Walk Test (6MWT)	30 days, 90 days, 365 days, 545 days, 730 days	Measure in meters
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo	30 days, 90 days, 365 days, 730 days
Number of all-cause deaths or all-cause hospitalizations	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)	30 days, 90 days, 365 days, 545 days, 730 days	Higher scores in the KCCQ reflect better health status
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT	180 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo	30 days, 90 days, 365 days, 730 days
Rate and number of cardiovascular death events	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure-related hospitalizations	30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo	30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT	180 days
Rate and number of heart failure death events	30 days, 90 days, 180 days, 365 days, 545 days, 730 days

Trial Locations

Locations (130)

Grandview Medical Group Research, LLC; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Dignity Health St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Phoenix Cardiovascular Research Group; 🇺🇸 Phoenix, Arizona, United States

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

Baptist Health Heart Failure & Transplant Institute; 🇺🇸 Little Rock, Arkansas, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Scripps Health; 🇺🇸 La Jolla, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente San Francisco; 🇺🇸 San Francisco, California, United States

Scroll for more (120 remaining)