REDUCE LAP-HF RANDOMIZED TRIAL I

REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

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