Surgical correction of tricuspid valve issues in patients receiving LVADs

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

This study is testing whether fixing tricuspid valve problems during the placement of a heart pump can help people with severe heart failure feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT02537769 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with advanced heart failure symptoms (NYHA Class III or IV) and mild tricuspid regurgitation scheduled for LVAD implantation.

Not a fit: Patients with prior tricuspid valve repair or significant structural tricuspid valve disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with heart failure receiving LVADs.

How similar studies have performed: Some recent studies suggest that correcting tricuspid valve issues during LVAD implantation may lead to improved outcomes, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Seattle, Washington

• 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

Conditions Tricuspid Regurgitation; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; LVAD; Tricuspid regurgitation; Heart failure; Transplant; 3D transesophageal echocardiography