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Transseptal ViMAC for Mitral Valve Disease (MITRAL-II Trial)
MITRAL-II Trial Summary
This trial is testing a new surgical technique, Transseptal Valve-in-MAC, for patients with severe mitral annular calcification and symptomatic mitral valve disease who are at high surgical risk. The control arm will receive medical treatment only.
MITRAL-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMITRAL-II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MITRAL-II Trial Design
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- My heart's mitral valve is severely narrowed or leaks badly.I am currently on antibiotics for an infection.My heart's left ventricle is severely weakened.I had a heart attack and needed a procedure to improve blood flow within the last 30 days.I had a stroke or a mini-stroke in the last 3 months.My heart team has approved me for surgery.I need emergency surgery.I haven't needed heart or lung support machines in the last 30 days.I have chosen not to undergo mitral valve surgery.I have a heart condition that blocks blood flow and my heart's measurements meet specific criteria.My heart's mitral valve ring does not have severe calcium buildup.My heart's shape or size doesn't allow for certain valve replacement procedures.I need treatment for my aortic valve disease.I have severe, unchangeable high blood pressure in my lungs.I need constant oxygen at home for my severe lung condition.I had a balloon valvuloplasty within the last 30 days.I have serious heart artery problems that haven't been treated with surgery.I had a heart procedure with a permanent implant within the last 30 days.I have severe heart valve issues with symptoms according to specific measurements.I have not had active upper GI bleeding in the last 90 days.I have not had a serious heart infection in the last 6 months.My heart's right side is not pumping well.I recently had COVID-19 with ongoing symptoms.My doctors consider surgery for my heart valve too risky.I am currently pregnant or breastfeeding.I have a history of blood disorders or clotting problems.I am 18 years old or older.I need surgery for severe heart valve leakage.I agree to follow all the study's required check-ups, including phone calls, for 5 years.I am considered at high risk for standard heart valve surgery by a cardiac surgeon.
Frequently Asked Questions
Are there any patients that fit the criteria for this research study currently being accepted?
"The listing on clinicaltrials.gov confirms that this research is actively recruiting patients. The 210 participants will be drawn from 22 different locations; the study was first posted on March 8th, 2021."
Where can patients receive this type of treatment?
"Beth Israel Deaconess Medical Center in Boston, Columbia University Medical Center in Detroit, and Brigham and Women's Hospital in Tulsa are all running this clinical trial, among other hospitals in 22 additional locations."
How many people are being asked to take part in this research project?
"In order to run this study as planned, the research team needs to enroll 210 individuals that fit the pre-specified inclusion criteria. Beth Israel Deaconess Medical Center in Boston, Massachusetts and Columbia University Medical Center in Detroit, Michigan are two of the many locations where potential participants can reside."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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