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Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients

NCT02537769 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-23

No results posted yet for this 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.

Conditions

  • Tricuspid Regurgitation
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV

Interventions

DEVICE

Left ventricular assist device (LVAD)

Left ventricular assist device placement (LVAD). All participants will receive an LVAD as a part of routine care for their advanced heart failure.

PROCEDURE

Tricuspid Valve Repair (TVR)

Participants will be randomly assigned to receive a tricuspid valve repair (TVR) to repair their tricuspid valve regurgitation in addition to an LVAD placement. Only half of enrolled participants will receive this procedure.

Sponsors & Collaborators

Principal Investigators

  • Kei Togashi, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02537769 on ClinicalTrials.gov