Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Tricuspid Regurgitation, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring LVAD, Tricuspid regurgitation, Heart failure, Transplant, 3D transesophageal echocardiography (TEE), 2D transesophageal echocardiography (TEE), Mild, Moderate
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Prior tricuspid valve repair
- Any evidence of structural (chordal or leaflet) tricuspid valve disease
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation
- Body Mass Index (BMI) > 45
- Pregnancy
- Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant
- 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
- 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)
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
- Any condition, other than heart failure, that could limit survival to less than 1 year
- Participant refuses to be enrolled in study
- Institution inmates.
Sites / Locations
- University of Washington Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
LVAD+TVR
LVAD only
In addition to left ventricular assist device (LVAD) placement with the inflow cannula in the left ventricular apex and outflow cannula placed in the ascending aorta, a repair of the regurgitating tricuspid valve will be performed. A Patent Foramen Ovale, if present, will be closed primarily. Echocardiographic parameters relevant to study will be collected throughout the procedure.
LVAD placement will be performed without additional tricuspid valve repair (TVR). The inflow cannula will be sutured to the left ventricular apex followed by the outflow cannula placed in the ascending aorta. This will be performed under cardiopulmonary bypass. Echocardiographic parameters relevant to study will be collected throughout the procedure.