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Tendyne Mitral Valve System for Mitral Regurgitation
Study Summary
This trial is testing a new mitral valve to see if it is safe and effective for people with severe mitral regurgitation who are not able to have surgery. Follow up evaluations will be done for 5 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have a blood clot in my heart's left side.I have a chest condition that prevents certain medical procedures.I have severe narrowing in my neck arteries causing symptoms.I need drugs or devices to help my heart pump during my planned procedure.I am 18 years old or older.I have no surgeries planned 30 days before or after the implant procedure.I have not had a heart attack in the last 30 days.I have not had a stroke in the last six months.I am currently on antibiotics for an infection.I have high blood pressure in the arteries of my lungs.I have severe leakage in my heart's mitral valve.I am not allergic to contrast dyes, blood thinners, nickel, or titanium.I am unable or unwilling to give consent for treatment.Your heart's left ventricle is larger than 7.0 cm when it's full of blood.I am on hemodialysis for chronic kidney failure.I have severe heart valve issues.A team of heart specialists has decided I can't have standard heart surgery.I have severe heart artery blockages that haven't been treated with stents or surgery.I have COPD and use oxygen at home.I have health issues not related to my heart that may shorten my life to under a year.I refuse to receive blood transfusions.I have a heart condition, but it's not due to dilated cardiomyopathy.I have blood disorders that cannot be treated effectively.Your heart's pumping ability is very low, as shown by a heart ultrasound.I had endocarditis less than 6 months ago.My heart condition affects my daily life even with treatment.I am unable or unwilling to follow the study's required tests and visits.I have severe issues with my heart's tricuspid valve or right ventricle.I have had surgery or a procedure on my heart valves.
- Group 1: Tendyne Mitral Valve System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there an opportunity for participants to join this experiment?
"Clinicaltrials.gov states this medical study is no longer actively seeking participants, as it was first posted on November 1st 2014 and last edited on July 26th 2022. However, 98 other trials are currently recruiting patients."
How many research centers are currently conducting this trial?
"Emory University Hospital in Atlanta, West virginia University in Morgantown, and Pinnacle Health - Harrisburg Hospital in Harrisburg are all sites currently recruiting patients for this clinical trial. An additional 7 locations have been identified as possible enrolment spots."
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