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NCT02537769 · ClinicalTrials.gov registry record · NA
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
A NA study of Tricuspid Regurgitation and Heart Failure NYHA Class III, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02537769: Recruiting NA study of Tricuspid Regurgitation and Heart Failure NYHA Class III, sponsored by University of Washington.
NCT02537769 is a NA study of Tricuspid Regurgitation and Heart Failure NYHA Class III that is actively recruiting participants, run by University of Washington. The registered enrollment target is 40 participants, below the 533-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02537769, a NA study of Tricuspid Regurgitation and Heart Failure NYHA Class III, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation. Despite these improved outcomes, procedure related length of hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One important reason for this is that many people experience right ventricular dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent studies suggest that correction of the TV during LVAD implantation has improved survival for those with severe regurgitation. However, this has not been evaluated for mild or moderate regurgitation. The goal of this study is to look at the clinical impact of surgical correction of mild to moderate TR in participants who are also undergoing LVAD implantation. The study will look at the degree of TR at various time points post-surgery, as well as any major cardiac adverse events, duration of hospitalization, and quality of life. The investigators hope to show that surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular dysfunction and have a positive impact on health outcomes.
Primary Outcome
Tricuspid Regurgitation (TR) severity as measured by vena contracta width and area will be assessed using echocardiography within 7 days prior to implantation (baseline) up to 13 months postoperative. TR severity is assessed on a range of mild to severe.
Conditions Studied
Interventions
- DEVICE Left ventricular assist device (LVAD)
- PROCEDURE Tricuspid Valve Repair (TVR)
Study Locations (1)
Washington
- University of Washington Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-08 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT02537769 shows while recruiting
NCT02537769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 533-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which Left ventricular assist device (LVAD) is the first listed.
NCT02537769 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT02537769 about?
NCT02537769 is a clinical study titled "Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients". The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and...
What is the current status of trial NCT02537769?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2015-08. Estimated completion is 2026-12.
What conditions does trial NCT02537769 study?
This clinical trial studies the following conditions: Tricuspid Regurgitation, Heart Failure NYHA Class III, Heart Failure NYHA Class IV.
What interventions are being tested in trial NCT02537769?
The interventions under investigation include: Left ventricular assist device (LVAD) (DEVICE), Tricuspid Valve Repair (TVR) (PROCEDURE).
Who is sponsoring clinical trial NCT02537769?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02537769 being conducted?
This trial has 1 study location across Washington. 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 NCT02537769's enrollment target sits among peer trials
40 14th of 17 higher than 4 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
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-
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-
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-
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
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-
Trisol System EFS Study
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-
EFS of the DUO System for Tricuspid Regurgitation
RECRUITING · NA
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