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

Functional Mitral Regurgitation Clinical Trial

Official title:

Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02671799
• Other study ID #: VenTouch CT004
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Mardil Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Description:

This trial is a prospective, multi-center, single-arm First-In-Man Continuation 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. 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 month, 3 months, 6 months, and 12, 24, and 36 months post-therapy adjustment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2020
• Est. primary completion date: July 4, 2017
• 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) 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

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• VenTouch System Implant
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.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague
France	Bordeaux Heart University Hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Mardil Medical

Countries where clinical trial is conducted

Czechia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluate Serious Adverse Event (SAE) rates at 6 months post-therapy adjustment		6 months
Secondary	Evaluate Serious Adverse Event (SAE) rates		Through 36 Months
Secondary	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
Secondary	Quantitative assessment of reverse remodeling based on change in LVEDD, LVEF, as measured by an echocardiographic core lab		Through 36 Months
Secondary	Improvement in patient symptoms as assessed by the NYHA functional class		Through 36 Months
Secondary	Improvement in Six-Minute Walk		Through 36 Months
Secondary	Improvement in Minnesota Living with Heart Failure Questionnaire		Through 36 Months

External Links

•   Study Sponsor Website