Actively Recruiting
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Led by University of Washington · Updated on 2021-02-23
40
Participants Needed
1
Research Sites
591 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
S
Society of Cardiovascular Anesthesiologists
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior tricuspid valve repair
- Any evidence of structural (chordal or leaflet) tricuspid valve disease
- Technical obstacles posing high surgical risk as judged by investigator
- Ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
- Body Mass Index (BMI) greater than 45
- Pregnancy
- Presence of mechanical aortic valve not converted to bioprosthesis at LVAD implant
- History of cardiac transplant or cardiomyoplasty
- Psychiatric disease, irreversible cognitive dysfunction, or psychosocial issues impairing study compliance
- Active, uncontrolled infection
- Intrinsic hepatic disease as defined by liver enzyme values
- Stroke within 90 days before enrollment or cerebral vascular disease with significant extracranial stenosis
- Need for chronic renal replacement therapy such as dialysis
- Participation in other clinical investigations that may affect study results
- Any condition other than heart failure limiting survival to less than 1 year
- Participant refusal to enroll in study
- Institution inmates
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
C
Cynthia Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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