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.
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