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NCT03775759 · ClinicalTrials.gov registry record · NA

Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study

A NA study of Heart Failure and Tricuspid Valve Insufficiency, sponsored by Duke University.

Completed
Registry status
NA
Development phase
71
Enrollment target
1
Study location

NCT03775759: Completed NA study of Heart Failure and Tricuspid Valve Insufficiency, sponsored by Duke University.

NCT03775759 is a NA study of Heart Failure and Tricuspid Valve Insufficiency that has completed, run by Duke University. The registered enrollment target is 71 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03775759, a NA study of Heart Failure and Tricuspid Valve Insufficiency, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
71 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repair or no tricuspid valve repair. The data will be analyzed as both an intention to treat analysis as well as an "as treated" analysis with the primary outcome being rates of right ventricular dysfunction post LVAD implantation. Tricuspid valve repair for these patient is currently being done for some patients, without any strong data to either support such practice or negate it.

Primary Outcome

Patients experiencing moderate or greater right heart failure as defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria

Interventions

  • PROCEDURE Tricuspid valve repair or replacement
  • OTHER Medical management of tricuspid regurgitation

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2018-08-22
Est. Completion 2023-02-15
Phase NA
Duke University

1,725 total trials

What the finished NCT03775759 record still lists

NCT03775759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower).

The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Tricuspid valve repair or replacement is the first listed.

NCT03775759 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03775759 about?

NCT03775759 is a clinical study titled "Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study". The purpose of this study is to determine the utility of tricuspid valve repair at the time of LVAD implantation for patients presenting with moderate or severe tricuspid regurgitation. The study will be a randomized trial for patients presenting for LVAD implantation to either tricuspid valve repai...

What is the current status of trial NCT03775759?

This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2018-08-22. Estimated completion is 2023-02-15.

What conditions does trial NCT03775759 study?

This clinical trial studies the following conditions: Heart Failure, Tricuspid Valve Insufficiency, Right Heart Failure.

What interventions are being tested in trial NCT03775759?

The interventions under investigation include: Tricuspid valve repair or replacement (PROCEDURE), Medical management of tricuspid regurgitation (OTHER).

Who is sponsoring clinical trial NCT03775759?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03775759 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Heart Failure

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 NCT03775759's enrollment target sits among peer trials

71 243rd of 397 higher than 153 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure 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

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Source: ClinicalTrials.gov NCT03775759, the US trial registry maintained by the National Library of Medicine. NCT03775759 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.