NCT02537769Recruiting
Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Source: ClinicalTrials.gov · Last updated 23 Feb 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 May 2015
- Start date
- 1 Aug 2015
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Washington
- Diseases
- Heart failure
- NCT number
- NCT02537769
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Aug 2015 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.