IRB Study Number FLA 18-047
Status Recruiting
Location Cleveland Clinic Florida
Institute Heart and Vascular Institute
Description
The REDUCE LAP-HF II study is being conducted to evaluate the clinical efficacy and safety of the InterAtrial Shunt Device (IASD®) System II for patients with elevated left atrial pressure who remain symptomatic despite appropriate medical management. Placed by an interventional cardiologist during a standard catheter-based procedure, the IASD system II creates a very small opening between the left and right atria. This opening allows blood to flow from the high pressure left atrium to the low pressure right atrium. This redistribution of blood to the right side potentially reduces the pressure in the left side and in the lungs.
Inclusion Criteria
• Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
o Symptoms of HF requiring current treatment with diuretics for > 30 days
o NYHA class II with a history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
o > 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), 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 Heart Failure (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.
Exclusion Criteria
• 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 below:
o ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF; o Cardiac index < 2.0 L/min/m2
o Inotropic infusion (continuous or intermittent) for EF< 40% within the past 6 months
o Patient is 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 (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
• Presence of significant valve disease defined by the site cardiologist as: o Mitral valve regurgitation defined as grade > 3+ MR o Tricuspid valve regurgitation defined as grade > 2+ TR o 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
• BMI >40
