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Mitral Valve Repair Device
Epicardial Device Implant for Mitral Regurgitation (ENRAPTUS Trial)
N/A
Waitlist Available
Led By Robert L Smith II, MD
Research Sponsored by Mitre Medical Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States
Patient is 22 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure through 30 days
Awards & highlights
ENRAPTUS Trial Summary
This trialstudies a heart surgery device to help with mitral insufficiency in patients with moderate to severe ischemia or functional mitral regurgitation.
Who is the study for?
This trial is for adults over 22 with moderate to severe ischemic or functional mitral regurgitation who are stable on heart failure therapy and scheduled for cardiac surgery. Exclusions include very weak heart function, advanced heart failure symptoms, large mitral valves, pregnancy, certain kidney issues, abnormal cardiac anatomy, prior valve interventions, and more.Check my eligibility
What is being tested?
The trial tests the Mitral Touch System's safety and performance in reshaping the mitral valve annulus during cardiac surgery. It aims to treat patients with significant mitral insufficiency through either a sternotomy or thoracotomy approach.See study design
What are the potential side effects?
Potential side effects may include complications from implanting the device such as infection risk at surgical site, bleeding complications due to surgery or cardiopulmonary bypass (CPB), potential damage to surrounding heart structures during implantation.
ENRAPTUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable heart failure treatment for the last 90 days.
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I am 22 years old or older.
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My heart valve leak was rated moderate or severe on an echo test.
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I am scheduled for heart surgery.
ENRAPTUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Freedom from Major Adverse Events
Secondary outcome measures
Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device
Rate of Technical Feasibility to implant the Mitral Touch Device
ENRAPTUS Trial Design
1Treatment groups
Experimental Treatment
Group I: Device ImplantationExperimental Treatment1 Intervention
To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.
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Who is running the clinical trial?
BSWRI Cardiac Imaging Core Lab (CICL)UNKNOWN
Mitre Medical Corp.Lead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
Robert L Smith II, MDPrincipal InvestigatorBaylor Scott and White Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition severely limits my physical activity.The investigator believes you have serious, permanent high blood pressure in your lungs.I cannot undergo procedures that require stopping my heart and lungs.I have been on a stable heart failure treatment for the last 90 days.I have scar tissue around my heart.My heart valve condition didn't improve after a procedure.Your heart has a diameter larger than 7 centimeters.I have a heart condition I was born with, but it's not PFO or ASD.You have calcium buildup in the arteries near where the procedure will take place, as seen in an angiogram.I am 22 years old or older.I am not pregnant, confirmed by a test or my menstrual history.I have a leaky heart valve due to myxomatous degeneration.I have been found to have an abnormal heart structure before or during surgery.I had a heart problem needing treatment within the last week.My heart valve leak was rated moderate or severe on an echo test.My kidney function is low (eGFR below 30).Your heart is not pumping enough blood.I am showing signs of a failing heart.Unable to measure certain heart measurements using a specific type of ultrasound.I have a structural problem with my mitral valve.I have had endocarditis before or have it now.I have liver cirrhosis or my liver is not functioning properly.I have had surgery or a less invasive procedure on my mitral valve.I am on long-term IV medication to strengthen my heart.I am scheduled for heart surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Device Implantation
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.
Could you confirm if participant enrollment is still open for this trial?
"According to the latest entry on clinicaltrials.gov, this medical experiment is no longer recruiting patients as of January 2nd 2023. Originating in September 10th 2023, there are presently 99 other trials accepting participants at this time."
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