Mitigating Post-Op RV Dysfunction After LVAD Implantation
NCT ID: NCT05758194
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-03-22
2025-03-28
Brief Summary
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Detailed Description
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This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standardized RV Management
Physicians will follow prespecified parameters for RV management (consistent with SOC)
Standardized RV Management
Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Usual Care RV Management
Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)
Usual Care RV Management
No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Interventions
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Standardized RV Management
Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Usual Care RV Management
No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Eligibility Criteria
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Inclusion Criteria
* Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
Exclusion Criteria
* Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent
* Pregnant patients
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Jonathan Grinstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB22-0972
Identifier Type: -
Identifier Source: org_study_id
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