Medtronic Care - HF: Study Overview

Indications, contraindications, warnings, precautions, and adverse events

Study Overview

Purpose		Assess the long-term effect of CRT on the morbidity and mortality of heart failure patients with left ventricular systolic dysfunction (LVSD) and cardiac dyssynchrony already receiving optimal medical therapy (OMT).
Study Design and Population		Randomized controlled, open-label trial 813 patients enrolled 82 centers 12 European countries Patients randomized as follows 409 CRT + OMT 404 to OMT alone Mean follow-up 29.4 months
Primary Endpoint		Combined all-cause mortality or unplanned hospitalization for a major cardiovascular event (CVE)
Secondary Endpoint		All-cause mortality Unplanned hospitalization with worsening heart failure NYHA classification Quality of Life Echocardiographic, biochemical, and hemodynamic assessments
Main Inclusion Criteria		Heart failure for at least 6 weeks NYHA Class III/IV LVSD and dilation -LVEF < 35% -LVEDD > 30 mm/m (height) Cardiac dyssynchrony as indicated by QRS width > 120 ms* OMT

Designed and managed by independent steering committee, evaluated by Data Safety Monitoring Board; sponsored by Medtronic, Inc.

*Patients with QRS 120-149 ms were required to meet echocardiographic evidence for ventricular dyssynchrony including aortic pre-ejection delay ≥ 140ms, interventricular mechanical delay > 40ms and delayed activation of posterolateral LV-wall.