Epicardial Device Implant for Mitral Regurgitation
(ENRAPTUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that within 90 days, patients should be on stable, optimally adjusted medical therapy for heart failure as recommended by current guidelines.
Is the epicardial device for mitral regurgitation safe for humans?
How is the Mitral Touch System treatment for mitral regurgitation different from other treatments?
The Mitral Touch System is unique because it involves an epicardial device implant, which means it is placed on the outer surface of the heart, potentially offering a less invasive alternative to traditional surgical methods that require opening the heart or using a catheter through blood vessels. This approach may be beneficial for patients with limited vascular access or other complications that make standard procedures challenging.678910
What data supports the effectiveness of the Mitral Touch System treatment for mitral regurgitation?
Research shows that the Mitral Touch System, an epicardial device, can effectively reduce mitral regurgitation (a condition where the heart's mitral valve doesn't close tightly) in animal models by reshaping the heart's structures. This suggests it may help improve heart function in similar human conditions.1341112
Who Is on the Research Team?
Robert L Smith II, MD
Principal Investigator
Baylor Scott and White Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Implantation
Epicardially reshape the mitral valve annulus and left ventricle using the Mitral Touch System without cardiopulmonary bypass
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mitral Touch System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mitre Medical Corp.
Lead Sponsor
BSWRI Cardiac Imaging Core Lab (CICL)
Collaborator