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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Left ventricular assist device (LVAD)

    Device

    Left 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/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: LVAD+TVRExperimental treatment 2 interventions
Group B: LVAD onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
13 months

Secondary outcomes

1

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.

Time frame
13 months
2

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.

Time frame
13 months

Other outcomes

1

Incidence of serious adverse events

Incidence of serious adverse events, per FDA definition.

Time frame
13 months
2

Post-procedure renal function

Post-procedure renal function as measured by serum creatinine (SCr) levels.

Time frame
13 months
3

Incidence of inotropic infusions

Incidence of inotropic infusions such as vasopressors, beta receptor agonists, and/or phosphodiestrase inhibitors.

Time frame
13 months
4

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.

Time frame
Time of postoperative discharge (an expected 10 days after surgery)

Sponsors and contacts

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University of Washington

Lead sponsor

Society of Cardiovascular Anesthesiologists

Collaborator