Functional Mitral RegurgitationNCT02671799
Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)
A study testing VenTouch System Implant in people with Functional Mitral Regurgitation, run by Mardil Medical at 2 sites in 2 countries.
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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- VenTouch System Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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].
Read the 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.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- VenTouch System Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenTouch System ImplantDevice
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: VenTouch System Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Evaluate Serious Adverse Event (SAE) rates at 6 months post-therapy adjustment
Measured: 6 months
Secondary outcomes (6)
Evaluate Serious Adverse Event (SAE) rates
Measured: 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
Measured: Through 36 Months
Quantitative assessment of reverse remodeling based on change in LVEDD, LVEF, as measured by an echocardiographic core lab
Measured: Through 36 Months
Improvement in patient symptoms as assessed by the NYHA functional class
Measured: Through 36 Months
Improvement in Six-Minute Walk
Measured: Through 36 Months
Improvement in Minnesota Living with Heart Failure Questionnaire
Measured: Through 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion4 Jul 2017
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardil Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671799
- Sponsor's protocol ID
- VenTouch CT004
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study
- ClinicalTrials.gov ID
- NCT02671799
- Acronym / sponsor ID
- VenTouch CT004
- Conditions
- Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mardil MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VenTouch System Implant | Experimental | Device: VenTouch System ImplantThe VenTouch System is indicated for patients who have moderately severe or severe functional mitral regurgitation (grade 3 or 4 MR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenTouch System ImplantThe 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. | Device | VenTouch System Implant |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Study Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VenTouch System Implant in people with Functional Mitral Regurgitation, run by Mardil Medical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.