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:
  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 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
  3. > 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

  • 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

Charlene Boisjolie, RN