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NeoChord DS1000 vs. Surgery for Mitral Valve Regurgitation (ReChord Trial)
ReChord Trial Summary
This trial is testing a new device to repair mitral valves without needing cardiopulmonary bypass. The goal is to see if it is safe and effective compared to the standard method.
ReChord Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowReChord Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ReChord Trial Design
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Who is running the clinical trial?
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- My heart valve leak is moderate to severe.I have a specific type of heart valve issue with a single abnormal blood flow detected.My body is suitable for the treatment based on its structure and overall health.I am a candidate for heart valve repair surgery with a heart-lung machine.My body is suitable for the treatment based on its structure.I need additional heart-related procedures.Your heart valve has a specific shape that would allow for the placement of chords in a certain way.I have had surgery on my mitral valve before.The front part of the valve covers at least 65% of the front-to-back distance, or the front part of the valve will close properly after the procedure.My heart valve condition involves specific segments with a unique leakage pattern.I have had heart surgery in the last 3 months.
- Group 1: Treatment Group
- Group 2: Control Group
- 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 many participants are joining the research experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this trial is actively seeking participants with an initial posting date of 11/3/2016 and a most recent update occurring 12/4/2019. The study has to recruit 585 patients from 15 different medical centres."
How many sites are hosting this clinical research?
"Patients can enroll in this medical trial at Sutter Health/Alta Bates Summitt Medical Center located in Oakland, Piedmont Heart Institute situated in Atlanta, and MedStar Washington Hospital Centre based in Washington DC. There are 12 other enrolment points throughout the US as well."
Is this research recruiting new participants at the present moment?
"Several sources, including clinicaltrials.gov, confirm that recruitment for this trial is ongoing; the initial posting was on November 3rd 2016 and the study has been updated as recently as December 4th 2019."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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