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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)
Must not have
Structural / organic TV disease
Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart valve condition.
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I am not currently in a clinical trial and do not plan to join another during this one.
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I do not have any other illnesses that would limit my life to less than 2 years.
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My liver is not working properly due to cirrhosis.
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I had a severe heart attack treated within the last week.
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I do not have cardiogenic shock currently.

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
871 Previous Clinical Trials
526,871 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,471 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,460,118 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
~44 spots leftby Jul 2025
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