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Device
VenTouch System for Mitral Regurgitation
N/A
Waitlist Available
Research Sponsored by Mardil Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial will test a new device to treat people with MR-related problems. The device is placed on the skin and sends electrical impulses to the affected area. The study will evaluate how well the device works and if it is safe.
Who is the study for?
This trial is for adults over 18 with moderate to severe functional mitral regurgitation due to cardiomyopathy, but without severe heart failure or other major heart conditions. Participants must have a certain range of left ventricular ejection fraction and size, be on stable heart failure medication, and may have a cardiac resynchronization therapy device if needed.Check my eligibility
What is being tested?
The VenTouch System is being tested in this study. It's a single-arm trial meaning all participants receive the intervention. The goal is to assess how safe and effective the system is at treating functional mitral valve regurgitation in patients who meet specific health criteria.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects could include complications related to the device implantation procedure such as infection, bleeding, or damage to nearby heart structures; issues with device function; or worsening of heart-related symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures
Secondary outcome measures
Evaluate Changes in Patient Functional Status by KCCQ
Evaluate Changes in Patient Functional Status by Six-Minute Walk
Evaluate Changes in Patient Symptoms by NYHA
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VenTouch System ImplantExperimental Treatment1 Intervention
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 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).
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Who is running the clinical trial?
Mardil MedicalLead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have heart problems that have been classified as moderate to severe by your doctor.You have a current widespread infection or bleeding.You have severe COPD and need oxygen therapy at home or take steroids regularly for your condition.You have severe heart failure according to the American College of Cardiology / American Heart Association.You are not able to walk at least 150 meters in six minutes.You have untreated serious heart artery problems.You have had certain heart surgeries or conditions that may affect the area around the heart.If you have had a heart procedure, a recent heart attack, or other serious heart issues in the last 30 days, you cannot participate.You have a condition that makes it unsafe for you to have surgery on your chest or heart, like severe breathing problems or inflammation of the heart.You have a serious problem with your mitral valve, like a tear, prolapse, or significant calcification.You have very high blood pressure in the arteries of your lungs that has been confirmed by medical tests.You have signs of serious heart problems on the right side of your heart, as seen on a heart ultrasound.You have needed help to support your heart within the past 30 days because it was not working well.You have a specific type of heart valve problem with severe symptoms, as confirmed by a heart ultrasound.Your heart's pumping ability, measured by echocardiography, is between 20% and 50%.You have been following the recommended treatment for heart failure for at least 30 days.If you need a CRT implant according to current guidelines, you must have it before joining the study. If you already have a CRT implant, it must have been in place for at least 90 days. If the settings of your CRT implant are changed to provide more efficient pacing, you must have had this change for at least 30 days.Your heart's left ventricle is a certain size as shown in an echocardiogram.The size of your left ventricle when your heart is relaxed is between 30 to 40 millimeters per square meter of your body size.You have a serious blockage in the carotid artery causing noticeable symptoms.You have a specific type of heart disease that is not dilated cardiomyopathy.You are expected to live for less than a year because of reasons other than your heart condition.You may need a heart device or transplant within the next year.You need to have any heart surgery.Your medical evaluation shows that surgery is too risky for you.Your kidneys are not working well and you need dialysis.You have an autoimmune disorder or are taking medication to lower your immune system.Your blood pressure is too low (systolic pressure less than 90 mmHg).You have had a stroke or mini-stroke within the last 30 days.You are 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: VenTouch System Implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being sought for this clinical experiment?
"Per information on clinicaltrials.gov, this research initiative is still actively enlisting volunteers; it was first advertised in March of 2019 and the details were updated most recently on September 8th 2020."
Answered by AI
How many sites are participating in the execution of this trial?
"Prospective participants can access this study at Montreal Heart Institute in Montreal, Quebec; University of British Columbia, St. Paul's Hospital in Vancouver, British Columbia; and London Health Sciences Centre, University Hospital in London Ontario. Additionally, there are 3 other sites available for enrollment."
Answered by AI
How many participants are being administered treatment as part of this trial?
"This trial necessitates the recruitment of 15 eligible patients. The sponsor, Mardil Medical, will be utilizing two medical centres to accomplish this task - Montreal Heart Institute in Montreal and University of British Columbia's St. Paul's Hospital in Vancouver."
Answered by AI
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