- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02671799
Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)
September 8, 2020 updated by: Mardil Medical
Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study
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].
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Autoimmune disorders and/or the use of immune suppression therapy
- Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating
- Currently enrolled in another investigational drug or device study
Intra-Operative Exclusion Criteria:
- Subjects with heart size outside of the offered VenTouch System size range
- 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)
- Signs/indications of ischemia
- Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Evaluate Serious Adverse Event (SAE) rates at 6 months post-therapy adjustment
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate Serious Adverse Event (SAE) rates
Time Frame: Through 36 Months
|
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
|
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
|
Through 36 Months
|
Improvement in patient symptoms as assessed by the NYHA functional class
Time Frame: Through 36 Months
|
Through 36 Months
|
Improvement in Six-Minute Walk
Time Frame: Through 36 Months
|
Through 36 Months
|
Improvement in Minnesota Living with Heart Failure Questionnaire
Time Frame: Through 36 Months
|
Through 36 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
July 4, 2017
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
January 20, 2016
First Submitted That Met QC Criteria
January 29, 2016
First Posted (Estimate)
February 2, 2016
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VenTouch CT004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Functional Mitral Regurgitation
-
Abbott Medical DevicesCompletedFunctional Mitral Regurgitation | Degenerrative Mitral RegurgitationRussian Federation
-
Ancora Heart, Inc.CompletedMitral Regurgitation | Mitral Valve Regurgitation | Functional Mitral RegurgitationAustria, Lithuania, Germany
-
Heinrich-Heine University, DuesseldorfCompletedMitral Regurgitation | Functional Mitral Regurgitation | Degenerative Mitral Valve RegurgitationGermany
-
Cardiac Dimensions Pty LtdTerminatedAtrial Fibrillation | Functional Mitral Regurgitation | Atrial Functional Mitral RegurgitationAustralia, Greece
-
Mitre Medical Corp.BSWRI Cardiac Imaging Core Lab (CICL)Not yet recruitingIschemic Mitral Regurgitation | Functional Mitral RegurgitationUnited States
-
Mardil MedicalRecruitingFunctional Mitral RegurgitationCanada, Hungary, France, Germany, Netherlands, Panama, Poland
-
Shanghai Shenqi Medical Technology Co., LtdActive, not recruitingFunctional Mitral RegurgitationChina
-
Jenscare ScientificEnrolling by invitationFunctional Mitral RegurgitationChina
-
Asklepios proresearchAbbottWithdrawn
-
Sun Yat-sen UniversityRecruitingFunctional Mitral RegurgitationChina
Clinical Trials on VenTouch System Implant
-
Mardil MedicalRecruitingFunctional Mitral RegurgitationCanada, Hungary, France, Germany, Netherlands, Panama, Poland
-
University of North Carolina, Chapel HillMed-El CorporationCompletedMeniere's Disease | Unilateral Acoustic NeuromaUnited States
-
Technische Universität DresdenCompletedZirconia Based Fixed Dental Prostheses
-
Medical University of GrazRecruiting
-
Azhar ALI ELSAYED SELEEMUnknownCrestal Bone Resorption | Implant Primary Stability | Implant Osseointegration
-
Boston Scientific CorporationCompletedBradycardia | Sinus Node DysfunctionUnited States, Israel, Singapore, Malaysia, Australia, Canada, China
-
IntegrumGöteborg University; Sahlgrenska University Hospital, SwedenActive, not recruiting
-
Matthew L. Carlson, M.D.Active, not recruiting
-
CardioKinetix, IncCompletedHeart FailureUnited States, Serbia
-
Morningside (Nantong) Medical Co.,LtdXiamen Cardiovascular Hospital, Xiamen UniversityRecruiting