Eligibility Details:
Inclusion Criteria:
1. Adults ≥18 years of age
2. Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic
or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by
echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)
3. NYHA Class II to IV
4. Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
5. Treatment and compliance with optimal guideline-directed medical therapy for heart
failure for at least 30 days
6. Subjects with a Class I indication for CRT implant according to current guidelines
should have CRT implant prior to entry into the study. Subjects who have existing CRT
implants may be included in the study if the implant has been in place for at least 90
days; reprogramming of an implanted CRT that results in increased biventricular pacing
(from <92% to ≥92%) must be in place for at least 30 days.
7. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by
echocardiography
8. Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where
LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
9. Subject is willing and available to return for study follow-up
10. Subject or legal representative understands and provides signed informed consent for
participation in study
11. Acceptance of subject for trial enrollment after review of all subject baseline data
by Study Selection Committee
Exclusion Criteria:
1. Life expectancy of less than 12 months due to conditions other than cardiac status
2. Anticipated need for LVAD or transplant within 12 months
3. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy
or chronic outpatient oral steroid use
4. American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart
failure
5. Six-minute walk distance < 150 meters
6. Identified need for any cardiovascular surgery
7. STS score that suggests prohibitive surgical risk as determined by Subject Selection
Committee
8. Untreated clinically significant coronary artery disease
9. Any procedure, condition or cardiac anatomy that may impact or compromise the
pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads,
pericarditis, or other procedure involving pericardial access)
10. Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI
myocardial infarction, unstable angina) or clinically significant cardiac events (e.g.
hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any
hospitalization) within 30 days of enrollment
11. Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress,
endocarditis, myocarditis, pericarditis)
12. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured
or elongated chordae, prolapsed valve, perforated valve leaflets, significant
calcification in the annulus, or calcification in the leaflets that restricts motion)
13. Severe symptomatic carotid stenosis
14. Severe or sustained pulmonary hypertension, defined by resting pulmonary artery
systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart
catheterization
15. Physical evidence of right-sided congestive heart failure with echocardiographic
evidence of moderate or severe right ventricular dysfunction or moderate to severe TR
16. Hypotension (systolic pressure <90 mmHg)
17. Hemodynamic instability requiring inotropic support or mechanical heart assistance
within 30 days
18. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart
disease causing heart failure other than dilated cardiomyopathy
19. UNOS status 1 heart transplantation
20. Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis
21. Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of
enrollment
22. Active systemic infection or bleeding
23. Autoimmune disorders and/or the use of immune suppression therapy
24. Females who are pregnant (as documented by HCG beta pregnancy test in females of
child-bearing age) or lactating
25. Currently enrolled in another investigational drug or device study
Intra-Operative Exclusion Criteria:
1. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured
or elongated chordae, prolapsed valve, perforated valve leaflets, significant
calcification in the annulus, or calcification in the leaflets that restricts motion)
2. Signs/indications of ischemia
3. Intra-operative coronary angiography demonstrates that there is compression of the
coronary arteries or reduction in coronary blood flow due to the VenTouch implant
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
