RecruitingNot ApplicableNCT02537769

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

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


Sponsor

University of Washington

Enrollment

40 participants

Start Date

Aug 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether repairing a leaky heart valve called the tricuspid valve at the same time as implanting a left ventricular assist device (LVAD — a mechanical pump that helps a failing heart pump blood) leads to better outcomes for patients with advanced heart failure. **You may be eligible if...** - You are 18 years of age or older - You have advanced heart failure (Class III or IV symptoms) - You have mild tricuspid valve leakage (regurgitation) - You are scheduled to receive an implantable LVAD - You or your legal representative can provide informed consent **You may NOT be eligible if...** - You have previously had tricuspid valve repair - You have structural damage to the tricuspid valve (e.g., torn valve tissue) - You have a BMI greater than 45 - You are pregnant - You have a mechanical aortic heart valve that won't be replaced at the time of LVAD surgery - You have previously had a heart transplant - You have an active, uncontrolled infection - You have had a stroke in the past 90 days - You require long-term dialysis for kidney failure - You have serious psychiatric conditions likely to interfere with device management Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELeft 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.

PROCEDURETricuspid 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.


Locations(1)

University of Washington Medical Center

Seattle, Washington, United States

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NCT02537769


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