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NCT02675244 · ClinicalTrials.gov registry record · NA

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

A NA study of Tricuspid Regurgitation and Mild Tricuspid Regurgitation, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
401
Enrollment target
20
Study locations

NCT02675244 is a NA study of Tricuspid Regurgitation and Mild Tricuspid Regurgitation that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 401 participants, below the 512-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT02675244, a NA study of Tricuspid Regurgitation and Mild Tricuspid Regurgitation, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
401 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • PROCEDURE TV Annuloplasty
  • PROCEDURE MVS

Study Locations (20)

Maryland

  • University of Maryland - Baltimore
  • Suburban Hospital - Bethesda
  • MedStar Health - Columbia

New York

  • Columbia University Medical Center - New York
  • Stony Brook Hospital - Stony Brook
  • Montefiore Einstein Heart Center - The Bronx

North Carolina

  • Mission Hospital - Asheville
  • Duke University - Durham
  • WakeMed Clinical Research Institute - Raleigh

California

  • University of Southern California - Los Angeles
  • Stanford University School of Medicine - Stanford

Ohio

  • Cleveland Clinic - Cleveland
  • Ohio State University - Columbus

Connecticut

  • Yale University School of Medicine - Yale-New Haven Hospital - New Haven

Georgia

  • Emory University - Atlanta

Michigan

  • University of Michigan Health Services - Ann Arbor

Trial Details

FieldValue
Enrollment Target 401 participants
Start Date 2016-05-26
Est. Completion 2021-04-19
Phase NA

What the Registry Record Tells You About NCT02675244

The ClinicalTrials.gov registry entry for NCT02675244 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 401 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 512-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (22% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which TV Annuloplasty is the first listed.

NCT02675244 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Maryland, New York, North Carolina.

Frequently Asked Questions

What is clinical trial NCT02675244 about?

NCT02675244 is a clinical study titled "Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery". 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,...

What is the current status of trial NCT02675244?

This trial is currently completed. It is a NA study. The enrollment target is 401 participants. The study started on 2016-05-26. Estimated completion is 2021-04-19.

What conditions does trial NCT02675244 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation, Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation.

What interventions are being tested in trial NCT02675244?

The interventions under investigation include: TV Annuloplasty (PROCEDURE), MVS (PROCEDURE).

Who is sponsoring clinical trial NCT02675244?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02675244 being conducted?

This trial has 20 study locations across California, Connecticut, Georgia, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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