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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02671799
• Date of registration: 20/01/2016
• Prospective Registration: No
• Primary sponsor: Mardil Medical
• Public title: Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)
• Scientific title: Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study
• Date of first enrolment: January 2016
• Target sample size: 15
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02671799
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, Czech Republic, Czechia, France, Malaysia, Netherlands

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adults =18 years of age

2. Symptomatic FMR of grade moderately severe to severe (3 to 4) with structurally normal
leaflets (preferably with echocardiographic evidence of EROA> 0.20 cm2)

3. NYHA Class II to IV

4. Left Ventricular Ejection Fraction (LVEF) 20%-50%

5. 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.

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.

7. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by
transthoracic echocardiography.

8. Subject is willing and available to return for study follow-up

9. Subject or legal representative understands and provides signed informed consent for
participation in study

10. 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. Identified need for any cardiovascular surgery

3. Untreated clinically significant coronary artery disease

4. 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)

5. 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

6. Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress,
endocarditis, myocarditis, pericarditis)

7. 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)

8. Severe symptomatic carotid stenosis

9. Severe or sustained pulmonary hypertension, defined by resting pulmonary artery
systolic (PAS) pressure greater than or equal to 70 mm Hg

10. Physical evidence of right-sided congestive heart failure with echocardiographic
evidence of moderate or severe right ventricular dysfunction

11. Hypotension (systolic pressure <90mm Hg)

12. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart
disease causing heart failure other than dilated cardiomyopathy

13. UNOS status 1 heart transplantation

14. Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis

15. Active systemic infection or bleeding

16. Autoimmune disorders and/or the use of immune suppression therapy

17. Females who are pregnant (as documented by HCG beta pregnancy test in females of
child-bearing age) or lactating

18. Currently enrolled in another investigational drug or device study

Intra-Operative Exclusion Criteria:

1. Subjects with heart size outside of the offered VenTouch System size range

2. 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)

3. Signs/indications of ischemia

4. Intra-operative coronary angiography demonstrates that there is compression of the
coronary arteries or reduction in coronary blood flow due to the VenTouch implant



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Functional Mitral Regurgitation

Intervention(s)

Device: VenTouch System Implant

Primary Outcome(s)

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 [Time Frame: 6 months]

Evaluate Serious Adverse Event (SAE) rates at 6 months post-therapy adjustment [Time Frame: 6 months]

Secondary Outcome(s)

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 [Time Frame: Through 36 Months]

Quantitative assessment of reverse remodeling based on change in LVEDD, LVEF, as measured by an echocardiographic core lab [Time Frame: Through 36 Months]

Evaluate Serious Adverse Event (SAE) rates [Time Frame: Through 36 Months]

Improvement in patient symptoms as assessed by the NYHA functional class [Time Frame: Through 36 Months]

Improvement in Minnesota Living with Heart Failure Questionnaire [Time Frame: Through 36 Months]

Improvement in Six-Minute Walk [Time Frame: Through 36 Months]

Secondary ID(s)

VenTouch CT004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors