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Procedure
TMCA for Mitral Regurgitation
N/A
Waitlist Available
Led By Robert J Lederman, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic functional mitral valve regurgitation
Adults age >=21 years
Must not have
Aortic stenosis more than mild in severity
Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 post procedure
Awards & highlights
No Placebo-Only Group
Summary
This trialtests a new device & technique to treat functional mitral valve regurgitation, instead of surgery, to reduce symptoms & hospital admissions.
Who is the study for?
This trial is for adults over 21 with functional mitral valve regurgitation, a heart condition causing leakage and failure. Participants must have symptoms like breathlessness or fluid buildup, be on stable heart medication for at least a month, and have specific heart function levels. Those who've had certain previous treatments like MitraClip can join if it's been over 30 days.
What is being tested?
The study tests a new catheter-based technique called Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat mitral valve leakage without surgery. It involves implanting devices that tighten around the valve to prevent leakage while protecting coronary arteries from being squeezed.
What are the potential side effects?
Potential side effects may include complications related to device implantation such as bleeding or infection, adverse reactions to X-ray and ultrasound used during the procedure, and possible impact on nearby heart structures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms from a leaking mitral valve in my heart.
Select...
I am 21 years old or older.
Select...
I have heart valve issues, reduced heart function, and severe heart failure symptoms.
Select...
I have moderate or severe leakage in my heart valve and symptoms of heart failure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have moderate to severe aortic stenosis.
Select...
I am scheduled for a heart valve surgery.
Select...
I am unable to give consent for participation on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 30 post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 post procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Primary Endpoint is Technical Success
Secondary study objectives
The Secondary Endpoint is Procedural Success
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcatheter Mitral Valve Cerclage AnnuloplastyExperimental Treatment1 Intervention
To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy.
The TMCA implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,919 Previous Clinical Trials
47,759,809 Total Patients Enrolled
Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
13 Previous Clinical Trials
886 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping function, as measured by echocardiography, CT, or CMR, is at least 20%.I have been on the best treatment for my condition for at least a month.I have symptoms from a leaking mitral valve in my heart.I am 21 years old or older.If you have a MitraClip that has come loose.I have heart valve issues, reduced heart function, and severe heart failure symptoms.I have moderate to severe aortic stenosis.I have moderate or severe leakage in my heart valve and symptoms of heart failure.I had a MitraClip implanted more than 30 days ago.I am scheduled for a heart valve surgery.Your heart's blood vessels are suitable for a specific heart procedure based on a previous imaging test.I am unable to give consent for participation on my own.My heart device leads are safe for a cerclage procedure, as confirmed by scans.You have a heart device that might get stuck by a cerclage.I had a heart valve replacement within the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Transcatheter Mitral Valve Cerclage Annuloplasty
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.
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