Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02537769

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

Led by University of Washington · Updated on 2021-02-23

40

Participants Needed

1

Research Sites

591 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

S

Society of Cardiovascular Anesthesiologists

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Prior tricuspid valve repair
  • Any evidence of structural (chordal or leaflet) tricuspid valve disease
  • Technical obstacles posing high surgical risk as judged by investigator
  • Ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
  • Body Mass Index (BMI) greater than 45
  • Pregnancy
  • Presence of mechanical aortic valve not converted to bioprosthesis at LVAD implant
  • History of cardiac transplant or cardiomyoplasty
  • Psychiatric disease, irreversible cognitive dysfunction, or psychosocial issues impairing study compliance
  • Active, uncontrolled infection
  • Intrinsic hepatic disease as defined by liver enzyme values
  • Stroke within 90 days before enrollment or cerebral vascular disease with significant extracranial stenosis
  • Need for chronic renal replacement therapy such as dialysis
  • Participation in other clinical investigations that may affect study results
  • Any condition other than heart failure limiting survival to less than 1 year
  • Participant refusal to enroll in study
  • Institution inmates

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

Loading map...

Research Team

C

Cynthia Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here