REDUCE LAP-HF RANDOMIZED TRIAL I

The primary objective of this randomized controlled clinical study is to evaluate the
peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the
IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left
sided filling pressures, and who remain symptomatic despite optimal Guideline Directed
Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

Key Inclusion Criteria:

- Chronic symptomatic Heart Failure

- Ongoing stable GDMT HF management and management of potential comorbidities

- Age ≥ 40 years old

- LV ejection fraction ≥ 40% within the past 3 months, without previously documented
ejection fraction <30%.

- Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP)
documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and
greater than RAP by ≥ 5 mm Hg

Key Exclusion Criteria:

- MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3
months, or current indication for coronary revascularization

- Cardiac Resynchronization Therapy initiated within the past 6 months

- Severe heart failure

- Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test >
600m

- History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or
pulmonary emboli within the past 6 months

- Presence of significant valve disease

- Known clinically significant untreated carotid artery stenosis

- Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation