Millipede System for Mitral Regurgitation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System for individuals with moderate to severe mitral regurgitation, a condition where the heart valve doesn't close properly, causing blood to flow backward. The treatment aims to repair the mitral valve without traditional open-heart surgery. Patients who continue to experience symptoms like shortness of breath or fatigue from this condition, even after following medical guidelines, might be suitable candidates if surgery isn't an option. As an unphased trial, this study provides patients with the opportunity to explore innovative treatment options that might not be available elsewhere.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to required medications like anticoagulation therapy, you may not be eligible.
What prior data suggests that the Millipede Transcatheter Annuloplasty Ring System is safe for mitral valve repair?
Research has shown that the Millipede Transcatheter Annuloplasty Ring System has been safely used in people. Studies have found that patients tolerate the device well. The Millipede system is designed to assist those with functional mitral regurgitation, a condition where the heart's mitral valve doesn't close properly.
Data from clinical studies indicate that the device can be placed using a less invasive method, which is generally easier on the body. Participants in these studies reported no major safety issues related to the device itself. This suggests that the treatment is well-tolerated and has a good safety record based on the available evidence.12345Why are researchers excited about this trial?
The Millipede Transcatheter Annuloplasty Ring System is unique because it offers a minimally invasive approach to repairing the mitral valve, which is a significant departure from traditional open-heart surgery. Unlike conventional treatments that may require extensive surgical procedures, this system is delivered via a catheter, reducing recovery time and associated risks. Researchers are excited because the Millipede System could provide an effective, less invasive option for patients with mitral regurgitation, potentially making treatment accessible to those who are not candidates for surgery.
What evidence suggests that the Millipede System is effective for mitral regurgitation?
Research has shown that the Millipede Transcatheter Annuloplasty Ring System holds promise for treating functional mitral regurgitation, a condition where the heart's mitral valve fails to close properly, causing blood to flow backward. Studies have found that this system effectively reduces the size of the mitral valve opening, helping to prevent backflow. Specifically, one study noted a decrease in the valve opening size from 38.0 mm to 25.9 mm after using the device. This suggests that the treatment can improve heart function in patients with this condition. The system has also demonstrated lasting effectiveness and durability in repairs. These findings support the potential of the Millipede System to effectively manage mitral regurgitation.13678
Who Is on the Research Team?
Susheel Kodali, MD
Principal Investigator
New York-Presbyterian/Columbia University Medical Center
Robert Gooley, MBBS, PhD
Principal Investigator
Monash Health
Prof. Nicolas Van Mieghem
Principal Investigator
Erasmus Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe functional mitral regurgitation who are symptomatic despite treatment, including CRT if needed. Candidates must be suitable for annuloplasty and not first-line candidates for valve surgery. Exclusions include severe allergies, certain heart conditions, recent strokes or surgeries, life expectancy under a year, and specific blood disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mitral valve repair using the Millipede Transcatheter Annuloplasty Ring System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Millipede Transcatheter Annuloplasty Ring System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology