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

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:

5. NYHA III,

6. NYHA ambulatory IV, or

7. NYHA II with a heart failure hospitalization within the prior 12 months (ofsigning the consent)

8. Able to complete six-minute walk test with distance between 100 m and 450 m.

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

10. "Stable" is defined as no more than a 100% increase or a 50% decrease of totaldaily doses. Medication changes within this range do not require any additionalwaiting before the screening assessments

11. When a total daily dose increase or decrease exceeds that which is consideredstable, the screening TTE and CT will be postponed 30 days after the medicationchange

12. When additional titration is required to optimize a subject's medication thatexceeds what is considered stable, the screening TTE and CT will be postponedat least 30 days after achieving the optimal dose (provided the optimal doseremains outside of the stable parameters)

13. When a dose-for-dose equivalent change in the class of medication change ismade, no additional waiting is required before the screening assessments

14. When a change in class medication change exceeds what is considered stable, ORa new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change

15. If an SGLT2 inhibitor is added to a subject's medications, the screening TTEand CT will be postponed at least 30 days after the addition

16. If an SGLT2 inhibitor dose changes per the stable definition above, noadditional waiting is required before the screening assessments

17. If an SGLT2 inhibitor dose change exceeds what is considered stable, thescreening TTE and CT will be postponed at least 30 days after achieving theoptimal dose (provided the dose remains outside of the stable parameters)

18. When applicable, for guideline-directed device-based therapies: a CRT devicemust be placed > 90 days before the screening TTE and CT, and an ICD must beplaced > 30 days before the screening TTE and CT

19. Able and willing to complete all qualifying diagnostic and functional tests, willingto accept blood product transfusion if required and agrees to comply with studyfollow-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) requiringrevascularization

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 screeningechocardiography and/or CT scan

5. Heart failure on the basis other than ischemic or non-ischemic dilatedcardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy,restrictive cardiomyopathy, uncorrected congenital heart disease, constrictivepericarditis)

6. Hemodynamic instability within 30 days prior to the implant defined as subjectrequiring inotropic support or mechanical hemodynamic support

7. Any planned cardiac surgery or interventions within the next 180 dayspost-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 tovasodilator therapy

11. History of any stroke within the prior 90 days of consent or documented ModifiedRankin 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 needfor 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 AVVmax >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 theAccuCinch 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 knownanaphylactoid or other non-anaphylactic allergic reactions to contrast agents thatcannot 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 documentedbirth control method, or who are lactating