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

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

What this study is about