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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-08-22 |
| Est. Completion | 2023-02-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03775759
The ClinicalTrials.gov registry entry for NCT03775759 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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