Tests tricuspid valve repair during heart pump implantation in heart failure patients
Tests repairing a leaking heart valve during heart pump implantation in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Key facts
- Where
- Seattle, United StatesSee the site
Where in United States
- University of Washington Medical CenterSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Washington
- Trial code
- NCT02537769
- Record updated
- 23 February 2021
- Original description
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.Read full original descriptionShow less
Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
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.
Inclusion: 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.
Exclusion: Prior tricuspid valve repair; Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator; Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant; History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis; Need for chronic renal replacement therapy (e.g. chronic dialysis); Any evidence of structural (chordal or leaflet) tricuspid valve disease; History of cardiac transplant or cardiomyoplasty; Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management; Presence of active, uncontrolled infection; Evidence of intrinsic hepatic disease as defined by liver enzyme values; Any condition, other than heart failure, that could limit survival to less than 1 year; Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation; Body Mass Index (BMI) > 45; Pregnancy; Participation in any other clinical investigation that is likely to confound study results or affect study outcome; Participant refuses to be enrolled in study; Institution inmates.