Presentation Details

LAPTOP-HF IDE Study [PPT 820224KB]

St. Jude Medical | October 28, 2009

LAPTOP-HF a conditionally approved IDE is a pivotal, controlled, randomized study evaluating twice daily LAP monitoring, combined with physician directed patient self management. The study is designed to evaluate 730 patients with NYHA class III heart failure and episodes of acute decompensation in up to 75 centers. The primary effectiveness endpoint is a reduction in heart failure related hospitalizations.