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

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ClinicalTrials.gov Identifier: NCT02537769
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Society of Cardiovascular Anesthesiologists
Information provided by (Responsible Party):
Kei Togashi, University of Washington

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Heart Failure NYHA Class III Heart Failure NYHA Class IV Device: Left ventricular assist device (LVAD) Procedure: Tricuspid Valve Repair (TVR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients
Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: LVAD+TVR
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.
Device: Left ventricular assist device (LVAD)
Left ventricular assist device placement (LVAD). All participants will receive an LVAD as a part of routine care for their advanced heart failure.

Procedure: Tricuspid Valve Repair (TVR)
Participants will be randomly assigned to receive a tricuspid valve repair (TVR) to repair their tricuspid valve regurgitation in addition to an LVAD placement. Only half of enrolled participants will receive this procedure.

Active Comparator: LVAD only
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.
Device: Left ventricular assist device (LVAD)
Left ventricular assist device placement (LVAD). All participants will receive an LVAD as a part of routine care for their advanced heart failure.




Primary Outcome Measures :
  1. Change in TR severity assessment from baseline [ Time Frame: 13 months ]
    Tricuspid Regurgitation (TR) severity as measured by vena contracta width and area will be assessed using echocardiography within 7 days prior to implantation (baseline) up to 13 months postoperative. TR severity is assessed on a range of mild to severe.


Secondary Outcome Measures :
  1. Change in quality of life (QOL) from baseline [ Time Frame: 13 months ]
    Functional status as measured by the Duke Activity Status Index (DASI) survey will be assessed within 7 days prior to implantation (baseline) up to 13 months postoperative.

  2. Change in RV function from baseline [ Time Frame: 13 months ]
    Right ventricular (RV) function as measured by tricuspid annular plane systolic excursion (TAPSE) values will be assessed using echocardiography prior to implantation (baseline) up to 13 months postoperative.


Other Outcome Measures:
  1. Incidence of serious adverse events [ Time Frame: 13 months ]
    Incidence of serious adverse events, per FDA definition.

  2. Post-procedure renal function [ Time Frame: 13 months ]
    Post-procedure renal function as measured by serum creatinine (SCr) levels.

  3. Incidence of inotropic infusions [ Time Frame: 13 months ]
    Incidence of inotropic infusions such as vasopressors, beta receptor agonists, and/or phosphodiestrase inhibitors.

  4. Duration of hospitalization after implant [ Time Frame: Time of postoperative discharge (an expected 10 days after surgery) ]
    Patients receiving an LVAD are expected to be discharged 10 days after the day of implantation. The actual length of hospitalization (measured from time after the surgery until postoperative discharge) will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537769


Contacts
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Contact: Cynthia Wu 206-616-1893 cw107@uw.edu

Locations
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United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Kei Togashi, MD, MPH    206-598-8755    ktogashi@uw.edu   
Contact: Burkhard Mackensen, MD, PhD    206-598-1462    gbmac@uw.edu   
Sponsors and Collaborators
University of Washington
Society of Cardiovascular Anesthesiologists
Investigators
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Principal Investigator: Kei Togashi, MD, MPH University of Washington
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Responsible Party: Kei Togashi, Assistant Professor, Division of Cardiothoracic Anesthesiology, University of Washington
ClinicalTrials.gov Identifier: NCT02537769    
Other Study ID Numbers: STUDY00000681
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kei Togashi, University of Washington:
LVAD
Tricuspid regurgitation
Heart failure
Transplant
3D transesophageal echocardiography (TEE)
2D transesophageal echocardiography (TEE)
Mild
Moderate
Additional relevant MeSH terms:
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Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases