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Evaluation of a device for heart failure treatment

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

Not applicable Interventional Ancora Heart, Inc. · NCT04331769

This study is testing if a new heart device can help people with heart failure feel better when used alongside their usual medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorAncora Heart, Inc. Industry-sponsored
Locations132 sites (Birmingham, Alabama and 131 other locations)
Trial IDNCT04331769 on ClinicalTrials.gov

What this trial studies

The CORCINCH-HF study is a prospective, randomized, open-label clinical investigation aimed at assessing the safety and efficacy of the AccuCinch Ventricular Restoration System in patients suffering from heart failure with reduced ejection fraction (HFrEF). Participants will be randomly assigned to either receive the AccuCinch device along with guideline-directed medical therapy or only guideline-directed medical therapy. The study will involve multiple centers internationally and will focus on patients with specific heart failure symptoms and ejection fraction measurements. The goal is to determine if the device can improve patient outcomes compared to standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older with symptomatic heart failure and reduced ejection fraction between 20% and 40%.

Not a fit: Patients with ejection fractions above 40% or those who do not meet the specific heart failure symptom criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that significantly improves heart function and quality of life for patients with HFrEF.

How similar studies have performed: Other studies have explored similar device-based interventions for heart failure, showing promising results, but the AccuCinch approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 131 other locations

+82 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure With Reduced Ejection FractionDilated CardiomyopathyHeart FailureReduced Ejection FractionCardiomyopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.