VenTouch OUS Feasibility Study
VenTouch OUS Feasibility Study
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the
 VenTouch System for treatment of subjects with functional MR.
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the
 VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who
 have been diagnosed with Grade 3-4 functional mitral valve regurgitation and deemed eligible
 per assessment by the inclusion/exclusion criteria. The duration of the study follow-up is 36
 months from the time of therapy adjustment. Data from this trial may be utilized in support
 of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be
 performed at 1, 3, 6, 12, 24, and 36 months post-therapy adjustment.
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