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

NCT02537769 | Recruiting DMC

• 1 other identifier: STUDY00000681
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  13 months

Secondary Outcomes (2)

• Change in quality of life (QOL) from baseline

  13 months

• Change in RV function from baseline

  13 months

Other Outcomes (4)

• Incidence of serious adverse events

  13 months

• Post-procedure renal function

  13 months

• Incidence of inotropic infusions

  13 months

Study Arms (2)

LVAD+TVR

EXPERIMENTAL

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.

Device: Left ventricular assist device (LVAD); Procedure: Tricuspid Valve Repair (TVR)

LVAD only

ACTIVE COMPARATOR

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.

Device: Left ventricular assist device (LVAD)

Interventions

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.

LVAD only; LVAD+TVR

Tricuspid Valve Repair (TVR) PROCEDURE

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.

LVAD+TVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead
• Society of Cardiovascular Anesthesiologists: collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kei Togashi, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Wu

CONTACT

206-616-1893; cw107@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Cardiothoracic Anesthesiology

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

US (1)