NCT02537769 Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
| NCT ID | NCT02537769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Tricuspid Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2015-08 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2015-08 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Kei Togashi, MD, MPH
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT02537769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02537769 currently recruiting?
Yes, NCT02537769 is actively recruiting participants. Contact the research team at cw107@uw.edu for enrollment information.
Where is the NCT02537769 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT02537769 clinical trial?
NCT02537769 is sponsored by University of Washington. The principal investigator is Kei Togashi, MD, MPH at University of Washington. The trial plans to enroll 40 participants.