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

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Heart Failure NYHA Class III, Heart Failure NYHA Class IV

In brief

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.

Key facts

Study ID

NCT02537769

Run by

University of Washington

People needed

40

Starts

2015-08-01

Expected to finish

2026-12-01

Last updated by the study team

2021-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant or their legal representative has signed an informed consent
• Over 18 years of age
• Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD

You may not qualify if…

• Prior tricuspid valve repair
• Any evidence of structural (chordal or leaflet) tricuspid valve disease
• Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
• Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
• Body Mass Index (BMI) > 45
• Pregnancy
• Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant
• History of cardiac transplant or cardiomyoplasty
• Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management
• Presence of active, uncontrolled infection
• Evidence of intrinsic hepatic disease as defined by liver enzyme values
• History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis
• Need for chronic renal replacement therapy (e.g. chronic dialysis)
• Participation in any other clinical investigation that is likely to confound study results or affect study outcome
• Any condition, other than heart failure, that could limit survival to less than 1 year
• Participant refuses to be enrolled in study
• Institution inmates.

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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