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Mechanical Heart Valve Replacement for Mitral Valve Disease
Study Summary
This trial is meant to show that it is safe and effective to offer a replacement mitral valve for patients whose anatomy is too small for the currently commercially available valves. 23 people were enrolled in total.
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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Who is running the clinical trial?
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- I have had a Ross procedure on my pulmonary valve.I am older than 5 years.I have an ongoing heart infection.I have a serious illness, not heart-related, limiting my life to under a year.I need a mitral valve replacement.I've had a recent neurological issue that hasn't improved for at least 30 days.My heart condition hasn't stabilized 2 days before the study.I need another heart surgery within a year after this study.I need a heart valve replacement.I can attend all required study visits and follow-ups.I am eligible for the study even if I am having other heart procedures.I cannot take blood thinners due to health reasons.I have active inflammation of the heart muscle.
- Group 1: Single device arm
- 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
How prolific is the deployment of this trial throughout the state?
"This clinical trial is conducted across 31 different sites, including those located in Spokane, Los Angeles and New york. For convenience sake, it would behove potential participants to choose the clinic nearest them for minimal travel requirements."
Is there still availability for patients to join the clinical trial?
"Clinicaltrials.gov states that this trial has closed recruitment, with the original post dating back to May 7th 2015 and last update on October 19th 2022. However, there are 15 other medical studies available for enrollment at present."
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