NCT05758194

Mitigating Post-Op RV Dysfunction After LVAD Implantation

Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.

Detailed description

The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations. 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

• Heart Failure
• Right Ventricular Dysfunction
• Right Ventricular Failure

Interventions

Type	Name	Description
OTHER	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)
OTHER	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)

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-12-31
• Completion: 2025-03-28
• First posted: 2023-03-07
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States