LAPTOP-HF

1. LAPTOP-HF Pivotal IDE Trial

2. Heart Failure Background Heart failure is one of the major public healthcare problems facing the developed world and has profound effects on the utilization of health care resources. Over five million (5,700,000) Americans have HF with 670,000 new cases diagnosed each year.1 Despite current recommendations for evaluation and management, HF morbidity and mortality remains high. In particular, readmission rates following a hospitalization for acute decompensated heart failure (ADHF) are 20% at 1 month, and nearly 50% at 6 months.2,3,4,5 About 90% of first time and recurrent HF hospitalizations present with clinical manifestations of pulmonary congestion.6,7

3. LAPTOP-HF Purpose The purpose of the LAPTOP-HF trial is to evaluate if a system which combines physician directed, patient self management, will reduce episodes of HF exacerbation, decompensation and hospitalizations.

4. 4 LAPTOP Study Design Overview LAPTOP-HF is conditionally approved by the FDA as a prospective, multi-center, randomized, pivotal IDE study Randomization 1:1 to sensor implanted providing ongoing LAP readings to the hand held along with physician prescribed medication recommendations OR no sensor implant but a hand-held device for medication reminders Patients will be stratified based on EF and need for CRM device therapy

5. Clinical Body of Evidence Initial experience with a left atrial pressure system was �well tolerated, feasible, and accurate at a short-term follow-up� 1. The next steps are to evaluate the clinical use of LAP monitoring.

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8. 8 Ischemic or non-ischemic cardiomyopathy for at least 6 months NYHA Class III symptoms at baseline Receiving maximal tolerated stable medical therapy per the ACC/AHA guidelines. Minimum of 1 prior HF hospital admission within the last 12 months