Heart Failure Clinical Trial
REDUCE LAP-HF RANDOMIZED TRIAL I
Summary
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
Full Description
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.
Eligibility Criteria
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
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There are 7 Locations for this study
Tucson Arizona, 85724, United States
New Haven Connecticut, 06510, United States
Chicago Illinois, 60611, United States
Evanston Illinois, 60201, United States
Houma Louisiana, , United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, , United States
Ann Arbor Michigan, 41809, United States
Rochester Minnesota, 55905, United States
New York New York, , United States
New York New York, , United States
New York New York, , United States
Winston-Salem North Carolina, , United States
Columbus Ohio, , United States
Columbus Ohio, , United States
Philadelphia Pennsylvania, , United States
Charleston South Carolina, , United States
Melbourne , , Australia
Aalst , , Belgium
Groningen , , Netherlands
Glasgow , , United Kingdom
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