RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-08
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02537769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant or their legal representative has signed an informed consent
  2. 2. Over 18 years of age
  3. 3. Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD
  1. 1. Prior tricuspid valve repair
  2. 2. Any evidence of structural (chordal or leaflet) tricuspid valve disease
  3. 3. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
  4. 4. Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
  5. 5. Body Mass Index (BMI) \> 45
  6. 6. Pregnancy
  7. 7. Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant
  8. 8. History of cardiac transplant or cardiomyoplasty
  9. 9. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management
  10. 10. Presence of active, uncontrolled infection
  11. 11. Evidence of intrinsic hepatic disease as defined by liver enzyme values
  12. 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. 13. Need for chronic renal replacement therapy (e.g. chronic dialysis)
  14. 14. Participation in any other clinical investigation that is likely to confound study results or affect study outcome
  15. 15. Any condition, other than heart failure, that could limit survival to less than 1 year
  16. 16. Participant refuses to be enrolled in study
  17. 17. Institution inmates.

Contacts and Locations

Study Contact

Cynthia Wu
CONTACT
206-616-1893
cw107@uw.edu

Principal Investigator

Kei Togashi, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Kei Togashi, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-08
Study Completion Date2026-12

Study Record Updates

Study Start Date2015-08
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Tricuspid Regurgitation
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV