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Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

NCT02675244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2024-06-18

Study results available
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Summary

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not.

At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

Conditions

  • Mild Tricuspid Regurgitation
  • Moderate Tricuspid Regurgitation
  • Tricuspid Regurgitation

Interventions

PROCEDURE

TV Annuloplasty

TV Annuloplasty will be performed using standard surgical techniques

PROCEDURE

MVS

MVS will be performed using standard surgical techniques

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • German Society for Thoracic and Cardiovascular Surgery

    collaborator OTHER

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Annetine C. Gelijns, PhD · Icahn School of Medicine at Mount Sinai

  • Richard Weisel, MD · Toronto General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-26
Primary Completion
2021-04-19
Completion
2021-04-19

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675244 on ClinicalTrials.gov