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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 below
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I am 18 years old or older.
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I have a condition where my mitral valve in the heart is not working properly, but it's not due to rheumatic heart disease.
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I am having surgery for valve disease in my heart and have moderate leaking or a large tricuspid valve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

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 more

Trial 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
858 Previous Clinical Trials
523,885 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,095 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,297 Total Patients Enrolled

Media Library

MVS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02675244 — N/A
Tricuspid Regurgitation Research Study Groups: MVS Alone, MVS + TV Annuloplasty
Tricuspid Regurgitation Clinical Trial 2023: MVS Highlights & Side Effects. Trial Name: NCT02675244 — N/A
MVS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02675244 — N/A

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
~45 spots leftby Apr 2025