REDUCE LAP-HF TRIAL
REDUCE LAP-HF TRIAL
The objective of this clinical study is to evaluate the safety and performance of the IASD
 System II in the treatment of heart failure patients with elevated left atrial pressure, who
 remain symptomatic despite appropriate medical management.
Key Inclusion Criteria:

 1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

 1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms
 (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion)
 at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating
 pulmonary congestion,) within past 12 months;

 2. One hospital admission for which HF was a major component of the hospitalization
 within the 12 months prior to study entry (transient heart failure in the context
 of myocardial infarction does not qualify);

 3. On-going management with recommended heart failure medications and comorbidities
 for several months according to the guidelines (2012 ESC Guidelines for diagnosis
 and Treatment of Acute and Chronic Heart Failure).

 2. Age ≥ 40 years old

 3. Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%

 4. Elevated left ventricular filling pressures with a gradient compared to CVP documented
 by :

 1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR

 2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

 Key Exclusion Criteria:

 3. Severe heart failure defined as:

 1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;

 2. Fick Cardiac Index < 2.0 L/min/m2

 3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months

 4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute
 Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of
 stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary
 emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8.
 Presence of significant valve disease defined by echocardiography as: a) Mitral valve
 regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as
 grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS