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Procedure
Surgical Techniques for Mitral Valve Disease (IMPROVE-FMR Trial)
N/A
Waitlist Available
Led By Sai Muralidhar Padala, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (month 6), post-intervention (month 12)
Awards & highlights
IMPROVE-FMR Trial Summary
This trial is testing two techniques to correct functional mitral regurgitation. The first part will test if a newer technique, papillary muscle approximation, is better than the current technique, undersizing mitral annuloplasty. The second part will test if the two techniques together are better than just undersizing mitral annuloplasty.
Who is the study for?
This trial is for adults with moderate or severe mitral regurgitation, which can be confirmed by an echocardiogram. Participants may have cardiomyopathy from ischemic or non-ischemic causes and could need coronary revascularization. People with recent psychiatric issues, pregnancy, structural mitral valve problems, contraindications for bypass surgery, recent heart attacks, previous mitral repairs, certain congenital heart diseases or severe kidney issues are excluded.Check my eligibility
What is being tested?
The study compares two surgical techniques to fix functional mitral regurgitation: undersizing mitral annuloplasty (UMA), a common method using a prosthetic ring; and papillary muscle approximation (PMA) combined with UMA. The goal is to see if PMA improves the durability of the repair by reducing leakage at various time points after surgery.See study design
What are the potential side effects?
Potential side effects include those associated with heart surgery such as bleeding, infection risk at the incision site or within the body post-surgery, reactions to anesthesia, blood clots leading to stroke or other complications and irregular heart rhythms.
IMPROVE-FMR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention (month 6), post-intervention (month 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (month 6), post-intervention (month 12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FMR Severity
Secondary outcome measures
All Cause Readmission Rate
Change in Functional Status assessed by 6-Minute Walk Test (6MWT)
Change in Left Ventricular Mass
+6 moreIMPROVE-FMR Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: UMA + PMA (Group 2)Experimental Treatment2 Interventions
Participants in the UMA + PMA group will receive an undersizing mitral annuloplasty (UMA) with papillary muscle approximation (PMA).
Group II: UMA (Group 1)Experimental Treatment1 Intervention
Participants in the UMA group will receive an undersizing mitral annuloplasty (UMA).
Group III: Retrospectively identified patientsActive Control1 Intervention
Retrospectively identified patients, who already underwent the standard of care surgery for the lesion of interest at Emory, within 6 months (± 1 month) after the date of their surgery, and are suitable for recruitment to the study for their post-operative research.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Papillary Muscle Approximation
2018
N/A
~40
Undersizing Mitral Annuloplasty
2018
N/A
~40
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,868 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,844 Previous Clinical Trials
47,817,309 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,252 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any physical problems with the mitral valve in your heart.You cannot undergo heart-lung machine treatment.You have symptoms showing your heart is not pumping enough blood.You have had a specific kind of heart attack in the past 14 days.You have a certain heart valve problem called mitral regurgitation that is moderate or severe.You have had surgery to fix your mitral valve in the past.You were born with a heart condition, except for a small hole in the heart called patent foramen ovale (PFO) or atrial septal defect (ASD).You have long-term kidney problems with high levels of creatinine or need ongoing treatment for kidney failure.You have heart muscle disease caused by reduced blood flow to the heart or other reasons, and may or may not need a heart procedure to improve blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: Retrospectively identified patients
- Group 2: UMA (Group 1)
- Group 3: UMA + PMA (Group 2)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to become involved with this research experiment?
"According to clinicaltrials.gov, recruitment for this trial remains ongoing since its initial posting on March 20th 2018 and latest alteration on December 8th 2021."
Answered by AI
How many individuals are being included in this medical exploration?
"Affirmative. The clinicaltrials.gov page is a testament to this ongoing study which first started accepting patients on March 20th, 2018 and was updated most recently in December 8th 2021. 140 participants are needed across three locations."
Answered by AI
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