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

Launched by UNIVERSITY OF WASHINGTON · Aug 28, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the effects of correcting a specific heart valve problem, called mild to moderate tricuspid regurgitation (TR), in patients who are receiving a left ventricular assist device (LVAD). An LVAD is a device that helps the heart pump blood when it’s not working properly, especially in patients with advanced heart failure. The researchers want to see if fixing the tricuspid valve during the LVAD surgery can improve patients' heart function, reduce hospital stays, and enhance their quality of life.

To be eligible for this trial, participants must be adults over 18 years old who have advanced heart failure symptoms and mild tricuspid regurgitation, and they need to be scheduled for LVAD surgery. Potential participants will be carefully evaluated, and those with certain heart conditions or other health issues may not qualify. If someone joins the study, they will be monitored closely after their surgery to assess their heart function and overall health. This trial is currently recruiting participants and aims to provide insights that could improve treatment for patients with heart failure.

Gender

ALL

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.