NCT02158403

PREVENtion of HeartMate II Pump Thrombosis

PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.

Detailed description

PREVENT is a prospective, multi-center, non-randomized study that is designed (1) to assess the incidence of HM II pump thrombosis in the current era when recommended practices for clinical management are adopted, and (2) to identify the risk factors associated with pump thrombosis events. The recommended practices are focused on implantation technique, anticoagulation regimen, pump speed and blood pressure management. All consecutive patients receiving a HM II implant will be considered for this study.

Conditions

• HeartMate II Pump Thrombosis

Interventions

Type	Name	Description
OTHER	Clinical Management Recommendations for reducing pump thrombosis	Clinical Management Recommendations for reducing pump thrombosis

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2014-06-06
• Last updated: 2022-03-25

Locations

23 sites across 1 country: United States