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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: Completed NA study of Tricuspid Regurgitation and Mild Tricuspid Regurgitation, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2016-05-26 |
| Est. Completion | 2021-04-19 |
| Phase | NA |
What the finished NCT02675244 record still lists
NCT02675244 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 512-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (22% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Tricuspid Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02675244's enrollment target sits among peer trials
401 8th of 17 higher than 10 of 17 other Tricuspid Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tricuspid Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
TTVR Early Feasibility Study
RECRUITING · NA
-
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
RECRUITING · NA
-
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
RECRUITING · NA
-
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
RECRUITING · NA
-
Trisol System EFS Study
RECRUITING · NA
-
EFS of the DUO System for Tricuspid Regurgitation
RECRUITING · NA
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