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Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients

RecruitingNAAges 18 Years - anyAllUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Left ventricular assist device (LVAD)
  • Tricuspid Valve Repair (TVR)
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Where

1 site
University of Washington Medical Center
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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