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

Phase 3

Recruiting

• Conditions: a condition that is caused by dilation of the wall of the pumping chamber of your heart; 10019280

• Registration Number: NL-OMON53754
• Lead Sponsor: Ancora Heart, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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:
a. NYHA III,
b. NYHA ambulatory IV, or
c. NYHA II with a heart failure hospitalizationa 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
7. Prior to randomization, 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
8. 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. Computed tomographic (CT), 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 (e.g.,
left ventricular assist device (LVAD))
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 high dose 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: Not specified