Clinical trial NCT03616678: VenTouch OUS Feasibility Study
Official title: Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Mitral Regurgitation
Lead sponsor: Mardil Medical
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures
timeFrame: Intra-operative
measure: Evaluate SAE Rates
timeFrame: 1 Month
Secondary outcomes:
measure: Evaluate SAE Rates
timeFrame: 36 Months
measure: Evaluate MR Severity
timeFrame: 36 Months
measure: Evaluate Reverse Ventricular Remodeling
timeFrame: 36 Months
measure: Evaluate Changes in Patient Symptoms by NYHA
timeFrame: 36 Months
measure: Evaluate Changes in Patient Functional Status by Six-Minute Walk
timeFrame: 36 Months
measure: Evaluate Changes in Patient Functional Status by KCCQ
timeFrame: 36 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute, University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia, St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ)
state: Quebec
city: Bordeaux
country: France
facility: Bordeaux Heart University Hospital
state: Pessac
city: Frankfurt
country: Germany
facility: CardioVasculäres Centrum
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Panama City
country: Panama
facility: Pacifica Salud Hospital Punta Pacifica
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawia
Study officials:
References: