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COMPLETED NA

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

NCT02675244 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02675244

The ClinicalTrials.gov registry entry for NCT02675244 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 401 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02675244 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Maryland, New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02675244?

The interventions under investigation include: TV Annuloplasty (PROCEDURE), MVS (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02675244?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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