IASD System II for Reducing Elevated Left Atrial Pressure in Heart Failure Patients

IASD System II

Incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months

Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for IV diuresis for HF up to 24 months, analyzed when the last subject completes 12 month follow-up, and time-to-first HF event

Change in baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score at 12 months

Cardiovascular mortality through 12 months

Non-fatal, ischemic stroke through 12 months

New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min/1.73 m2) through 12 months

Incidence of Major Cardiac Events i. Cardiac death ii. Myocardial infarction iii. Cardiac tamponade iv. Emergency cardiac surgery.

Thrombo-embolic complications (TIA, systemic embolization) through 12 months

≥30% increase in right ventricular size/decrease in TAPSE through 12 months

Newly acquired persistent or permanent AF or atrial flutter through 12 months

Total rate per patient year of heart failure admissions or healthcare facility visits for IV diuresis or visits with intensification of oral diuresis for HF through 24 months, analyzed when the last subject completes 12 months follow-up

Change in New York Heart Association (NYHA) functional Class between baseline and 12 months

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.