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Procedure
Concurrent Tricuspid Valve Repair During Mitral Surgery for Tricuspid Regurgitation
N/A
Waitlist Available
Led By Annetine C. Gelijns, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Degenerative mitral valve disease refers to a spectrum of conditions in which morphologic changes in the connective tissues of the mitral valve cause structural lesions such as chordal elongation, chordal rupture, leaflet tissue expansion, and annular dilation typically resulting in mitral regurgitation due to leaflet prolapse. This definition excludes rheumatic heart disease (Anyanwu AC, Adams DH. (2007) Etiological classification of degenerative mitral valve disease: Barlow's disease and fibroelasticity deficiency. Semin Thorac Cardiovasc Surg; 19(2): 90-6)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial will compare two groups of patients- those who have their TV repaired at the time of their MVS, and those who do not.
Who is the study for?
Adults undergoing mitral valve surgery for degenerative mitral regurgitation, with mild to moderate tricuspid regurgitation or a dilated tricuspid annulus. Candidates must be able to consent and comply with study follow-up. Exclusions include pacemaker/defibrillator leads across the tricuspid valve, recent heart attack, pregnancy, other investigational therapies, liver failure, severe pulmonary hypertension, severe tricuspid regurgitation, additional cardiac surgeries (with some exceptions), cardiogenic shock.Check my eligibility
What is being tested?
The trial is testing if repairing the tricuspid valve at the same time as planned mitral valve surgery improves heart health in patients with mild to moderate tricuspid regurgitation. It aims to settle debates on whether concurrent TV repair should be standard practice during MVS for these patients.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of heart surgery may include bleeding, infection at the incision site, reactions to anesthesia, blood clots leading to stroke or lung problems; and rarely more serious complications such as organ damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a condition where my mitral valve in the heart is not working properly, but it's not due to rheumatic heart disease.
Select...
I am having surgery for valve disease in my heart and have moderate leaking or a large tricuspid valve.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Treatment Failure
Secondary outcome measures
Diuretic Use
Economic Measures (Inpatient Costs)
EuroQoL (EQ-5D)
+19 moreTrial Design
2Treatment groups
Active Control
Group I: MVS AloneActive Control1 Intervention
Participants will undergo mitral valve surgery alone.
Group II: MVS + TV AnnuloplastyActive Control2 Interventions
Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,107 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,813,704 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for valve disease in my heart and have moderate leaking or a large tricuspid valve.The doctor thinks that your body is not managing fluids well.I have a heart valve condition.I am 18 years old or older.The doctor thinks you have very serious, permanent high blood pressure in your lungs.You have a pacemaker or defibrillator with leads that cross from the right atrium to the right ventricle.I am not currently in a clinical trial and do not plan to join another during this one.I have a condition where my mitral valve in the heart is not working properly, but it's not due to rheumatic heart disease.I am not having heart surgery except for specific types like PVI, Maze, LAA closure, PFO or ASD closure, or CABG.You have a serious problem with the backflow of blood in your heart, as confirmed by a special heart ultrasound test.I do not have any other illnesses that would limit my life to less than 2 years.My liver is not working properly due to cirrhosis.It seems like the phrase "Functional MR" is incomplete. Could you please provide more context or details so that I can accurately summarize the criterion for you?I had a severe heart attack treated within the last week.I do not have cardiogenic shock currently.
Research Study Groups:
This trial has the following groups:- Group 1: MVS Alone
- Group 2: MVS + TV 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open recruitment opportunities for this trial?
"Clinicaltrials.gov states that this clinical trial is not actively looking for participants at the moment, having been initially posted on May 26th 2016 and recently updated on November 7th 2022. However, 40 other studies are open to recruitment right now."
Answered by AI
How many locations are participating in this experiment within the state's borders?
"Baylor College of Medicine in Houston, Texas, University of Michigan Health Services in Ann Arbor, Michigan, and University of Pennsylvania in Philadelphia are amongst the 32 sites hosting this medical trial."
Answered by AI
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