Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)

NCT02671799 | Unknown DMC

• 1 other identifier: VenTouch CT004
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for treatment of moderate to moderate-severe functional mitral valve regurgitation \[FMR\].

Conditions

Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• Evaluate mean reduction in MR, and freedom from grade 3 and 4 MR at 6 months post-therapy adjustment, as measured by an echocardiographic core lab

  6 months

• Evaluate Serious Adverse Event (SAE) rates at 6 months post-therapy adjustment

  6 months

Secondary Outcomes (6)

• Evaluate Serious Adverse Event (SAE) rates

  Through 36 Months

• Evaluate mean reduction in MR, and freedom from grade 3 and 4 MR, as demonstrated by quantitative measures, as measured by an echocardiographic core lab

  Through 36 Months

• Quantitative assessment of reverse remodeling based on change in LVEDD, LVEF, as measured by an echocardiographic core lab

  Through 36 Months

• Improvement in patient symptoms as assessed by the NYHA functional class

  Through 36 Months

• Improvement in Six-Minute Walk

  Through 36 Months

Study Arms (1)

VenTouch System Implant

EXPERIMENTAL

The VenTouch System is indicated for patients who have moderately severe or severe functional mitral regurgitation (grade 3 or 4 MR).

Device: VenTouch System Implant

Interventions

VenTouch System Implant DEVICE

The VenTouch System is intended for use in the treatment of functional MR (FMR) in adults who are symptomatic despite optimal medical management. It is intended for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable mainly to annular dilatation with or without papillary muscle displacement. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is used to reshape the base of the heart to bring the mitral valve leaflets into better coaptation. By doing so, it brings the mitral valve leaflets closer, allowing proper closure of the valve, and reducing or eliminating MR. There is provision of support to the ventricular myocardium below the annulus as well as the annulus, so the VenTouch System may allow long-term ventricular remodeling with positive impact on the functionality of the mitral valve.

VenTouch System Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age
• Symptomatic FMR of grade moderately severe to severe (3 to 4) with structurally normal leaflets (preferably with echocardiographic evidence of EROA\> 0.20 cm2)
• NYHA Class II to IV
• Left Ventricular Ejection Fraction (LVEF) 20%-50%
• Treatment with optimal guideline-directed medical therapy for heart failure for at least 30 days. Subjects must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless, in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry. Stable is defined as no more than a 100% increase or a 50% decrease in dose.
• 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.
• Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by transthoracic echocardiography.
• Subject is willing and available to return for study follow-up
• Subject or legal representative understands and provides signed informed consent for participation in study
• Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee

You may not qualify if:

• Life expectancy of less than 12 months due to conditions other than cardiac status
• Identified need for any cardiovascular surgery
• Untreated clinically significant coronary artery disease
• 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)
• 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
• Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
• 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)
• Severe symptomatic carotid stenosis
• Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure greater than or equal to 70 mm Hg
• Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
• Hypotension (systolic pressure \<90mm Hg)
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy
• UNOS status 1 heart transplantation
• Creatinine \> 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis
• Active systemic infection or bleeding

Sponsors & Collaborators

• Mardil Medical: lead

Study Sites (2)

Na Homolce Hospital

Prague, 15030, Czechia

Location

Bordeaux Heart University Hospital

Bordeaux, 33604, France

Location

Related Links

• Study Sponsor Website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: July 4, 2017
• Study Completion: December 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); FR (1)