VenTouch OUS Feasibility Study

Functional Mitral Regurgitation Clinical Trial

Official title:

Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03616678
• Other study ID #: VenTouch CT007
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2020
• Source: Mardil Medical
• Contact: Sarah Hase, BS
• Phone: 763-710-4518
• Email: shase[@]mardil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• VenTouch System
The VenTouch™ System consists of a delivery tool with a pre-loaded implant (VenTouch device) and accessories, which include a sizing tool, PEMS, chamber positioning tool, and accessories kit with luer fitting, tubing clamp, and titanium plug. The VenTouch device is offered in 6 sizes, with 4 different sized inflatable chambers available. Please refer to the VenTouch Instructions for Use for and system details. The VenTouch device consists of three (3) inflatable silicone chambers attached to the wall of a knitted polyester support. The VenTouch device is implanted around the base of the heart and positioned at the level of the atrio-ventricular (AV) groove and the adjacent ventricular muscle. The VenTouch device is composed of biocompatible, medical-grade silicone and polyester.

Locations

Country	Name	City	State
Canada	Libin Cardiovascular Institute, University of Calgary	Calgary	Alberta
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ)	Québec City	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	University of British Columbia, St. Paul's Hospital	Vancouver	British Columbia
France	Bordeaux Heart University Hospital	Bordeaux	Pessac
Germany	CardioVasculäres Centrum	Frankfurt
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Netherlands	Leiden University Medical Center	Leiden
Panama	Pacifica Salud Hospital Punta Pacifica	Panama City
Poland	Centralny Szpital Kliniczny MSWiA w Warszawia	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Mardil Medical

Countries where clinical trial is conducted

Canada,  France,  Germany,  Hungary,  Netherlands,  Panama,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures	Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)	Intra-operative
Primary	Evaluate SAE Rates	Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment	1 Month
Secondary	Evaluate SAE Rates	Evaluate Serious Adverse Event (SAE) rates	36 Months
Secondary	Evaluate MR Severity	Evaluate MR severity reduction and mitral valve dimension reduction via echocardiographic core lab assessment	36 Months
Secondary	Evaluate Reverse Ventricular Remodeling	Evaluate reverse ventricular remodeling via echocardiographic core lab assessment	36 Months
Secondary	Evaluate Changes in Patient Symptoms by NYHA	Evaluate changes in patient symptoms as assessed by the NYHA functional class	36 Months
Secondary	Evaluate Changes in Patient Functional Status by Six-Minute Walk	Evaluate changes in patient functional status as assessed by Six-Minute Walk	36 Months
Secondary	Evaluate Changes in Patient Functional Status by KCCQ	Evaluate changes in patient functional status as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	36 Months

External Links

•   Study Sponsor Website