PREVENtion of HeartMate II Pump Thrombosis (PREVENT)

Abbott

Status: Completed

Conditions: HeartMate II Pump Thrombosis

Treatments: Other: Clinical Management Recommendations for reducing pump thrombosis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02158403

TC05232014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject or legally authorized representative has signed an informed consent form
• Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD)

Exclusion criteria

• Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)
• Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Clinical Management Recommendations

Other group

Description:

Clinical management recommendations for reducing pump thrombosis

Treatment:

Other: Clinical Management Recommendations for reducing pump thrombosis