About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Left ventricular assist device (LVAD)
DeviceLeft ventricular assist device placement (LVAD). All participants will receive an LVAD as a part of routine care for their advanced heart failure.
Tricuspid Valve Repair (TVR)
Procedure/SurgeryParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in TR severity assessment from baseline
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.
Secondary outcomes
Change in quality of life (QOL) from baseline
Functional status as measured by the Duke Activity Status Index (DASI) survey will be assessed within 7 days prior to implantation (baseline) up to 13 months postoperative.
Change in RV function from baseline
Right ventricular (RV) function as measured by tricuspid annular plane systolic excursion (TAPSE) values will be assessed using echocardiography prior to implantation (baseline) up to 13 months postoperative.
Other outcomes
Incidence of serious adverse events
Incidence of serious adverse events, per FDA definition.
Post-procedure renal function
Post-procedure renal function as measured by serum creatinine (SCr) levels.
Incidence of inotropic infusions
Incidence of inotropic infusions such as vasopressors, beta receptor agonists, and/or phosphodiestrase inhibitors.
Duration of hospitalization after implant
Patients receiving an LVAD are expected to be discharged 10 days after the day of implantation. The actual length of hospitalization (measured from time after the surgery until postoperative discharge) will be recorded.
Sponsors and contacts
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University of Washington
Lead sponsor
Society of Cardiovascular Anesthesiologists
Collaborator