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Annuloplasty Ring System
Millipede System for Mitral Regurgitation
N/A
Waitlist Available
Led By Robert Gooley, MBBS, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has moderate to severe (3+) or severe (4+) functional mitral regurgitation confirmed by echocardiography core lab
Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post index procedure
Awards & highlights
Study Summary
This trial will test a new device to treat people with a heart condition that causes leaking of the mitral valve.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the Millipede Transcatheter Annuloplasty Ring System's feasibility and safety in patients with functional mitral regurgitation. It involves placing a ring via catheter to repair the heart's mitral valve without open-heart surgery.See study design
What are the potential side effects?
Potential side effects may include reactions to contrast used during the procedure (if not premedicated), complications from accessing the heart through veins or septum, issues related to device materials like nickel or titanium, and general risks associated with catheter-based interventions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve leak is moderate to severe, confirmed by an echo.
Select...
I still have heart symptoms despite following my treatment plan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ index procedure exit from the catheterization laboratory
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index procedure exit from the catheterization laboratory
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Safety Endpoint
Primary Technical Success Endpoint
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mitral Valve RepairExperimental Treatment1 Intervention
All subjects will receive mitral valve repair using the Millipede System
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
718 Previous Clinical Trials
932,944 Total Patients Enrolled
Robert Gooley, MBBS, PhDPrincipal InvestigatorMonash Health
Nicolas Van Mieghem, MD, PhDPrincipal InvestigatorErasmus Medical Center
2 Previous Clinical Trials
652 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a device implanted to help my heart beat in rhythm within the last 3 months.I need oxygen therapy for my COPD.I am on the waiting list for a heart transplant or have had one before.I have severe heart issues on the right side, confirmed by an echo.You cannot have a certain type of heart test, or the study cannot measure a specific heart condition using a common heart test.I have heart surgery planned within the next year.You have an artificial heart valve.I had surgery on my neck artery within the last 30 days.I have severe narrowing or leaking of my aortic valve.I am allergic to certain medications or metals like nickel or titanium.I am considered a candidate for annuloplasty as determined by the medical team and confirmed by the CRC.I have had a stroke or a mini-stroke in the last 30 days.I have a heart condition that needs treatment but hasn't been treated yet.Doctors have found it not possible to access my heart through my leg vein.I have not had any heart or blood vessel procedures in the last 30 days.I have not had any heart or blood vessel surgery (except for carotid surgery) in the last 3 months.I need surgery urgently for a health issue.I have severe liver disease.Your blood has low levels of hemoglobin or platelets, or high levels of white blood cells.You are expected to live for less than 12 months.You have previously had surgery to close a hole in your heart called atrial septal defect (ASD) or patent foramen ovale (PFO).You are allergic to contrast dye and cannot take medicine to prevent a reaction.You show signs of having a blood clot inside your heart.My kidneys are not working well, but I am not on dialysis.Your blood pressure in the pulmonary artery is consistently higher than 70 mmHg.You have severe calcification in the mitral valve or other physical features that make you unsuitable for a specific type of heart treatment, as determined by your doctor.I am currently pregnant, breastfeeding, or plan to become pregnant during the study.My heart team agrees surgery is not my first treatment option.My heart valve leak is moderate to severe, confirmed by an echo.I still have heart symptoms despite following my treatment plan.I am 18 years old or older.I had endocarditis or a serious infection within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Mitral Valve Repair
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.
Is there still an opportunity for individuals to enroll in this experiment?
"The clinicaltrials.gov website showcases that this trial is no longer recruiting patients, although the study was first posted on November 13th 2019 and last updated on November 28th 2022. Despite this medical research project's closure, there are still 517 other studies actively seeking participants at present."
Answered by AI
What is the geographical distribution of this clinical trial?
"The trial is being run in seven separate locations, including Minneapolis, Thousand Oaks and Bronx. To limit travel demands for participants, it's best to select the closest medical centre possible."
Answered by AI
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