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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671799
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mardil Medical

Tracking Information
First Submitted Date  ICMJE January 20, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date July 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Evaluate mean reduction in MR at 6 months post-therapy adjustment, as measured by an echocardiographic core lab [ Time Frame: 6 months ]
  • Evaluate 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Evaluate Serious Adverse Event (SAE) rates [ Time Frame: 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 [ 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 ]
  • Improvement in patient symptoms as assessed by the NYHA functional class [ Time Frame: Through 36 Months ]
  • Improvement in Six-Minute Walk [ Time Frame: Through 36 Months ]
  • Improvement in Minnesota Living with Heart Failure Questionnaire [ Time Frame: Through 36 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Evaluate Serious Adverse Event (SAE) rates at 12 months post-therapy adjustment [ Time Frame: 12 months ]
  • Evaluate mean reduction in MR at 12 months post-implant, as measured by an echocardiographic core lab [ Time Frame: 12 months ]
  • Evaluate freedom from grade 3 and 4 MR at 12 months post-implant, as measured by an echocardiographic core lab [ Time Frame: 12 months ]
  • Assessment of reverse remodeling based on change in LVEDD at 12 months [ Time Frame: 12 months ]
  • Assessment of reverse remodeling based on change in LVEF at 12 months [ Time Frame: 12 months ]
  • Improvement in patient symptoms as assessed by the NYHA functional class through 12 months [ Time Frame: 12 months ]
  • Improvement in Six-Minute Walk through 12 months [ Time Frame: 12 months ]
  • Improvement in Minnesota Living with Heart Failure Questionnaire through 12 months [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)
Official Title  ICMJE Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study
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].
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Functional Mitral Regurgitation
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: VenTouch System Implant
The VenTouch System is indicated for patients who have moderately severe or severe functional mitral regurgitation (grade 3 or 4 MR).
Intervention: Device: VenTouch System Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date July 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France
Removed Location Countries Canada,   Czech Republic,   Malaysia,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02671799
Other Study ID Numbers  ICMJE VenTouch CT004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mardil Medical
Study Sponsor  ICMJE Mardil Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mardil Medical
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP