REDUCE LAP-HF Randomized Trial II
To evaluate the clinical efficacy and safety of the Corvia Medical InterAtrial Shunt Device (IASD® System II) in symptomatic heart failure patients with an LV ejection fraction less than or equal to 40%, and elevated left sided filling pressures despite Guideline Directed Medical Therapy (GDMT).
Heart & Vascular - Structural Heart Trials,
Heart & Vascular
Sameer Gafoor, MD and John Mignone, MD, PhD
Key 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 Class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dypsnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion) within 12 months; AND
- > 1 HF hospital admission (with HF as the primary or secondary diagnosis); or treatment with IV or intensification of oral diuresis for HF in a healthcare facility (ER/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 >40% within the past 3 months, without previously documented EF <30% (within 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.
Key Exclusion Criteria
Charlene Boisjolie, RN