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Functional Mitral RegurgitationNCT03616678

VenTouch OUS Feasibility Study

A study testing VenTouch System in people with Functional Mitral Regurgitation, run by Mardil Medical at 12 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR. 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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
12 sitesin 7 countries
Study dates
25 Mar 2019to 31 Dec 2023
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) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)
  • NYHA Class II to IV
  • Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
  • Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days
  • 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; reprogramming of an implanted CRT that results in increased biventricular pacing (from <92% to ≥92%) must be in place for at least 30 days.
Show all 11Show fewer
  • Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography
  • Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
  • 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
  • Anticipated need for LVAD or transplant within 12 months
  • Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
  • American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure
  • Six-minute walk distance < 150 meters
  • Identified need for any cardiovascular surgery
Show all 29Show fewer
  • STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee
  • 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 ≥70 mmHg determined by echocardiography or right heart catheterization
  • Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR
  • Hypotension (systolic pressure <90 mmHg)
  • Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days
  • 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
  • Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment
  • 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:
  • 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

12 sites in 7 countries.

Sarah Hase, BS contact

763-710-4518

shase@mardil.com

12 sites in 7 countries

Canada6 sites, 6 recruiting

  • Libin Cardiovascular Institute, University of Calgary

    Calgary, Alberta, T2N 4N1

    William Kent, MD, 403-944-5480, william.kent@albertahealthservices.ca

    William Kent, MD

    Not yet recruiting

  • London Health Sciences Centre, University Hospital

    London, Ontario, N6A 5A5

    Stephanie Fox, BA, RRT, 519-685-8500 ext. 35031, Stephanie.Fox@lhsc.on.ca

    Dave Nagpal, MD

    Not yet recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Manon Vervais, 514-376-3330 ext. 3783, manon.vervais@icm-mhi.org

    Anita Asgar, MD

    Recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ)

    Québec, Quebec, G1V4G5

    Hugo Tremblay, 418-656-8711 ext. 3797, hugo.tremblay@criucpq.ulaval.ca

    François Dagenais, MD

    Recruiting

  • Toronto General Hospital

    Toronto, Ontario, 4NU-470

    Shakira Christie, Shakira.Christie@uhn.ca

    Vivek Rao, MD, PhD

    Recruiting

  • University of British Columbia, St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Catherin Mok, 604-806-8383, CMok@providencehealth.bc.ca

    Anson Cheung, MD

    Not yet recruiting

Other trials in Canada

France1 site

  • Bordeaux Heart University Hospital

    Bordeaux, Pessac, 33604

    Withdrawn

Other trials in France

Germany1 site

  • CardioVasculäres Centrum

    Frankfurt, 60389

    Withdrawn

Other trials in Germany

Hungary1 site, 1 recruiting

  • Semmelweis University Heart and Vascular Center

    Budapest

    Orsolya Kemenes, +36 20 8250511, studycenter.sekk@gmail.com

    Béla Merkely, MD, PhD

    Recruiting

Other trials in Hungary

Netherlands1 site

  • Leiden University Medical Center

    Leiden, 2300 RC

    Withdrawn

Other trials in Netherlands

Panama1 site, 1 recruiting

  • Pacifica Salud Hospital Punta Pacifica

    Panama City, 0801

    Margelis Muñoz, (507) 6499-9304, margelismunoz@gmail.com

    Christian Marin y Kall, 305-799-1435, marinykallch@hotmail.com

    Recruiting

Other trials in Panama

Poland1 site

  • Centralny Szpital Kliniczny MSWiA w Warszawia

    Warsaw, 02-507

    Withdrawn

Other trials in Poland

About this study

Official title: Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study

This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

Read the detailed description

This is a prospective, multi-center, single-arm 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 and deemed eligible per assessment by the inclusion/exclusion criteria. 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, 3, 6, 12, 24, and 36 months post-therapy adjustment.

Being tested
VenTouch System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenTouch SystemDevice

    The VenTouch™ System consists of a delivery tool with a pre-loaded implant (VenTouch device) and accessories, which include a sizing tool, PEMS, chamber positioning tool, and accessories kit with luer fitting, tubing clamp, and titanium plug. The VenTouch device is offered in 6 sizes, with 4 different sized inflatable chambers available. Please refer to the VenTouch Instructions for Use for and system details.

    The VenTouch device consists of three (3) inflatable silicone chambers attached to the wall of a knitted polyester support. The VenTouch device is implanted around the base of the heart and positioned at the level of the atrio-ventricular (AV) groove and the adjacent ventricular muscle. The VenTouch device is composed of biocompatible, medical-grade silicone and polyester.

Study groups in NCT03616678
Study groupRoleWhat they receive
VenTouch System ImplantExperimentalThe VenTouch System is intended for use in the treatment of functional MR (FMR) in adults who are symptomatic despite optimal medical management. It is indicated for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable to annular and/or ventricular dilation. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is intended to provide ventricular support that will encourage beneficial remodeling of the heart and, with adjustable inflatable chambers, it is intended to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation, allowing proper closure of the valve, and reducing or eliminating MR. The VenTouch System is indicated for patients who have "moderately severe" or "severe" mitral regurgitation (grade 3 or 4 MR).
Receives: Device: VenTouch System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures

    Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)

    Measured: Intra-operative

  2. Evaluate SAE Rates

    Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment

    Measured: 1 Month

Secondary outcomes (6)

  1. Evaluate SAE Rates

    Evaluate Serious Adverse Event (SAE) rates

    Measured: 36 Months

  2. Evaluate MR Severity

    Evaluate MR severity reduction and mitral valve dimension reduction via echocardiographic core lab assessment

    Measured: 36 Months

  3. Evaluate Reverse Ventricular Remodeling

    Evaluate reverse ventricular remodeling via echocardiographic core lab assessment

    Measured: 36 Months

  4. Evaluate Changes in Patient Symptoms by NYHA

    Evaluate changes in patient symptoms as assessed by the NYHA functional class

    Measured: 36 Months

  5. Evaluate Changes in Patient Functional Status by Six-Minute Walk

    Evaluate changes in patient functional status as assessed by Six-Minute Walk

    Measured: 36 Months

  6. Evaluate Changes in Patient Functional Status by KCCQ

    Evaluate changes in patient functional status as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Measured: 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start25 Mar 2019
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616678
Sponsor's protocol ID
VenTouch CT007
Status last verified
Sep 2020
First submitted
24 Jul 2018
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VenTouch System in people with Functional Mitral Regurgitation, run by Mardil Medical at 12 sites in 7 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 11 inclusion and 29 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 12 sites in Canada, France, Germany, Hungary, Netherlands and 2 more countries. 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?

Contact Sarah Hase, BS (763-710-4518, shase@mardil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures (time frame: Intra-operative). 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?

On the ClinicalTrials.gov record for NCT03616678.

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.

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