Trial Purpose and Description
The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction ≥40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
Ages: 40 years and older
SELECT INCLUSION CRITERIA
- Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- Symptoms of HF requiring current treatment with diuretics for > 30 days
- 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
- > 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.
SELECT 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:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF;
- Cardiac index < 2.0 L/min/m2
- Inotropic infusion (continuous or intermittent) for EF< 40% within the past 6 months
- 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:
- 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
Corvia Medical, Inc.
Start Date: 07/26/2017
End Date: 09/30/2019
Last Updated: 02/22/2018
Study HIC#: 2000020740