Recruiting

Surgical Correction

Sponsor:

University of Washington

Code:

NCT02537769

Conditions

Tricuspid Regurgitation

Heart Failure NYHA Class III

Heart Failure NYHA Class IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Left ventricular assist device (LVAD)

Tricuspid Valve Repair (TVR)

Study Details

Brief 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

Study ID

NCT02537769

Start date

Aug, 2015

Status verified date

Feb, 2021

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LVAD+TVR

In addition to left ventricular assist device (LVAD) placement with the inflow cannula in the left ventricular apex and outflow cannula placed in the ascending aorta, a repair of the regurgitating tricuspid valve will be performed. A Patent Foramen Ovale, if present, will be closed primarily. Echocardiographic parameters relevant to study will be collected throughout the procedure.

active comparator: LVAD only

LVAD placement will be performed without additional tricuspid valve repair (TVR). The inflow cannula will be sutured to the left ventricular apex followed by the outflow cannula placed in the ascending aorta. This will be performed under cardiopulmonary bypass. Echocardiographic parameters relevant to study will be collected throughout the procedure.

Interventions

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.

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.

Primary outcome measure

  • Change in TR severity assessment from baseline [ Time Frame: 13 months ]

Central Contacts and Locations

Central contacts

Locations

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Kei Togashi, MD, MPH

206-598-8755ktogashi@uw.edu

Burkhard Mackensen, MD, PhD

206-598-1462gbmac@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Feb 23, 2021

Last verified

Feb, 2021

Keywords

  • LVAD
  • Tricuspid regurgitation
  • Heart failure
  • Transplant
  • 3D transesophageal echocardiography (TEE)
  • 2D transesophageal echocardiography (TEE)
  • Mild
  • Moderate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2021-02-23.