Chronic symptomatic Heart Failure (HF) documented by one or more of the following: * (1) Symptoms of HF requiring current treatment with diuretics for > 30 days, * (2) NYHA class II with a history of > NYHA class II, NYHA class III or ambulatory NYHA class IV symptoms at screening, or signs within past 12 months, (AND) * 1 hospital admission with HF as primary or secondary diagnosis, or treatment with intravenous or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry, (OR) an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months;

Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of HF (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose change for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months;

Age > 40 years old, LV ejection fraction (EF) > 40% within the past 3 months, without previously documented EF <30% (within the past 5 years);

Elevated LA pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise > 25mmHg, and greater than RAP by > 5 mmHg OR a > 10 mmHg increase of end-expiratory PCWP during supine ergometer exercise compared to resting PCWP, and greater than RAP by > 5 mmHg;

MI and/or percutaneous cardiac intervention within past 3 months, CABG in past 3 months or current indication for coronary revascularization, AVR (surgical AVR or TAVR) within the past 12 months;

Cardiac Resynchronization Therapy initiated within the past 6 months;

Severe heart failure defined as one or more of the following: (1) ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF, (2) Cardiac index < 2.0 L/min/m2, (3) Inotropic infusion (continuous or intermittent) for EF< 40% within the past 6 months, (4) On the cardiac transplant waiting list;

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

History of stroke, transient ischemic attack, deep vein thrombosis, or pulmonary emboli within the past 6 months;

Presence of significant valve disease defined by site cardiologist as Mitral valve regurgitation defined as grade > 3+ MR, Tricuspid valve regurgitation defined as grade > 2+ TR, Aortic valve disease defined as > 2+ AR or > moderate AS;

Known clinically significant untreated carotid artery stenosis;

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

• 1601

• Cardiovascular Diseases

• Chronic symptomatic Heart Failure

• Heart Diseases

• Heart Failure

• Intervention

• Cardiology

• Corvia Medical