Surgical correction of tricuspid valve issues in patients receiving LVADs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the clinical impact of correcting tricuspid valve regurgitation during the implantation of left ventricular assist devices (LVAD) in patients with advanced heart failure. Participants will be randomly assigned to receive either LVAD implantation alone or LVAD implantation with surgical repair of the tricuspid valve. The study aims to enroll 30 to 40 patients over two years, focusing on those with mild tricuspid regurgitation. Comprehensive preoperative assessments will be conducted to evaluate the participants' heart function and overall health.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Washington Medical Center
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Kei Togashi, MD, MPH — University of Washington
• Study coordinator: Cynthia Wu
• Email: cw107@uw.edu
• Phone: 206-616-1893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.