REDUCE LAP-HF TRIAL II

Description

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Study Start Date

June, 01 2017

Estimated Completion Date

July 2024

Interventions

  • Other: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
  • Device: IASD System II implant

Study ID

Corvia Medical -- Protocol 1601

Status

Recruiting

Trial ID

NCT03088033

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

380

Sponsor

Corvia Medical

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

    Gender

    All

    Ages

    40 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (162)

    Study Location Distance Name Phone Email
    Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Gregory Lewis MD None None
    Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Gregory Lewis MD None None
    Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Gregory Lewis MD None None
    Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Gregory Lewis MD None None
    Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Gregory Lewis MD None None
    Yale University - New Haven, Connecticut 119.2 miles Michael Chen MD None None
    Yale University - New Haven, Connecticut 119.2 miles Michael Chen MD None None
    Yale University - New Haven, Connecticut 119.2 miles Michael Chen MD None None
    Yale University - New Haven, Connecticut 119.2 miles Michael Chen MD None None
    Yale University - New Haven, Connecticut 119.2 miles Michael Chen MD None None
    Mt Sinai Hospital - New York, New York 183.2 miles Srinivas Dukkupati MD None None
    Mt Sinai Hospital - New York, New York 183.2 miles Srinivas Dukkupati MD None None
    Mt Sinai Hospital - New York, New York 183.2 miles Srinivas Dukkupati MD None None
    Mt Sinai Hospital - New York, New York 183.2 miles Srinivas Dukkupati MD None None
    Mt Sinai Hospital - New York, New York 183.2 miles Srinivas Dukkupati MD None None
    Morristown Memorial Hospital - Morristown, New Jersey 206.3 miles None None None
    Morristown Memorial Hospital - Morristown, New Jersey 206.3 miles None None None
    Hackensack University Medical Center - Hamilton, New Jersey 237.1 miles None None None
    Hackensack University Medical Center - Hamilton, New Jersey 237.1 miles None None None
    Hackensack University Medical Center - Hamilton, New Jersey 237.1 miles None None None
    University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jeremy Mazurek MD None None
    University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jeremy Mazurek MD None None
    University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jeremy Mazurek MD None None
    University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jeremy Mazurek MD None None
    University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Jeremy Mazurek MD None None
    Medstar Washington Hospital Center - Washington, D.C., District of Columbia 391.7 miles None None None
    UPMC Presbyterian Hospital - Pittsburgh, Pennsylvania 478.5 miles None None None
    UPMC Presbyterian Hospital - Pittsburgh, Pennsylvania 478.5 miles None None None
    University of Virginia - Charlottesville, Virginia 493.4 miles Jamie Kennedy MD None None
    University of Virginia - Charlottesville, Virginia 493.4 miles Jamie Kennedy MD None None
    University of Virginia - Charlottesville, Virginia 493.4 miles Jamie Kennedy MD None None
    University of Virginia - Charlottesville, Virginia 493.4 miles Jamie Kennedy MD None None
    University of Virginia - Charlottesville, Virginia 493.4 miles Jamie Kennedy MD None None
    Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
    Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
    Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
    Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
    Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
    Duke University Medical Center - Durham, North Carolina 609.0 miles None None None
    Duke University Medical Center - Durham, North Carolina 609.0 miles None None None
    Duke University Medical Center - Durham, North Carolina 609.0 miles None None None
    Duke University Medical Center - Durham, North Carolina 609.0 miles None None None
    Ohio Health - Columbus, Ohio 640.9 miles Anupam Basuray MD None None
    Ohio Health - Columbus, Ohio 640.9 miles Anupam Basuray MD None None
    Ohio Health - Columbus, Ohio 640.9 miles Anupam Basuray MD None None
    Ohio Health - Columbus, Ohio 640.9 miles Anupam Basuray MD None None
    Ohio Health - Columbus, Ohio 640.9 miles Anupam Basuray MD None None
    Ohio State University College of Medicine - Columbus, Ohio 641.8 miles Rami Kahwash MD None None
    Ohio State University College of Medicine - Columbus, Ohio 641.8 miles Rami Kahwash MD None None
    Ohio State University College of Medicine - Columbus, Ohio 641.8 miles Rami Kahwash MD None None
    Ohio State University College of Medicine - Columbus, Ohio 641.8 miles Rami Kahwash MD None None
    Ohio State University College of Medicine - Columbus, Ohio 641.8 miles Rami Kahwash MD None None
    Wake Forest - Winston-Salem, North Carolina 659.2 miles Bharathi Upadya MD None None
    Wake Forest - Winston-Salem, North Carolina 659.2 miles Bharathi Upadya MD None None
    Wake Forest - Winston-Salem, North Carolina 659.2 miles Bharathi Upadya MD None None
    Wake Forest - Winston-Salem, North Carolina 659.2 miles Bharathi Upadya MD None None
    Wake Forest - Winston-Salem, North Carolina 659.2 miles Bharathi Upadya MD None None
    University of Michigan Health System - Ann Arbor, Michigan 727.3 miles Scott Hummel None None
    University of Michigan Health System - Ann Arbor, Michigan 727.3 miles Scott Hummel None None
    University of Michigan Health System - Ann Arbor, Michigan 727.3 miles Scott Hummel None None
    University of Michigan Health System - Ann Arbor, Michigan 727.3 miles Scott Hummel None None
    Christ Hospital Ohio Heart and Vascular Institute - Cincinnati, Ohio 737.9 miles None None None
    Christ Hospital Ohio Heart and Vascular Institute - Cincinnati, Ohio 737.9 miles None None None
    Christ Hospital Ohio Heart and Vascular Institute - Cincinnati, Ohio 737.9 miles None None None
    Christ Hospital Ohio Heart and Vascular Institute - Cincinnati, Ohio 737.9 miles None None None
    Christ Hospital Ohio Heart and Vascular Institute - Cincinnati, Ohio 737.9 miles None None None
    Medical University of South Carolina - Charleston, South Carolina 821.2 miles Sheldon Litwin MD None None
    Medical University of South Carolina - Charleston, South Carolina 821.2 miles Sheldon Litwin MD None None
    Medical University of South Carolina - Charleston, South Carolina 821.2 miles Sheldon Litwin MD None None
    Medical University of South Carolina - Charleston, South Carolina 821.2 miles Sheldon Litwin MD None None
    Medical University of South Carolina - Charleston, South Carolina 821.2 miles Sheldon Litwin MD None None
    Northwestern University - Chicago, Illinois 847.9 miles Mark Ricciardi MD None None
    Northwestern University - Chicago, Illinois 847.9 miles Mark Ricciardi MD None None
    Northwestern University - Chicago, Illinois 847.9 miles Mark Ricciardi MD None None
    Northwestern University - Chicago, Illinois 847.9 miles Mark Ricciardi MD None None
    Northwestern University - Chicago, Illinois 847.9 miles Mark Ricciardi MD None None
    University of Chicago Medical Center - Chicago, Illinois 848.0 miles None None None
    Swedish Medical Center - Seattle, Washington 848.0 miles None None None
    University of Chicago Medical Center - Chicago, Illinois 848.0 miles None None None
    Swedish Medical Center - Seattle, Washington 848.0 miles None None None
    University of Chicago Medical Center - Chicago, Illinois 848.0 miles None None None
    Swedish Medical Center - Seattle, Washington 848.0 miles None None None
    Swedish Medical Center - Seattle, Washington 848.0 miles None None None
    Swedish Medical Center - Seattle, Washington 848.0 miles None None None
    Evanston Northshore Healthcare - Evanston, Illinois 850.4 miles Robert Gordon MD None None
    Evanston Northshore Healthcare - Evanston, Illinois 850.4 miles Robert Gordon MD None None
    Evanston Northshore Healthcare - Evanston, Illinois 850.4 miles Robert Gordon MD None None
    Evanston Northshore Healthcare - Evanston, Illinois 850.4 miles Robert Gordon MD None None
    Evanston Northshore Healthcare - Evanston, Illinois 850.4 miles Robert Gordon MD None None
    Piedmont Hospital Research Institute - Atlanta, Georgia 934.9 miles None None None
    Piedmont Hospital Research Institute - Atlanta, Georgia 934.9 miles None None None
    Piedmont Hospital Research Institute - Atlanta, Georgia 934.9 miles None None None
    Vanderbilt University - Nashville, Tennessee 942.2 miles Deepak Gupta None None
    Vanderbilt University - Nashville, Tennessee 942.2 miles Deepak Gupta None None
    Vanderbilt University - Nashville, Tennessee 942.2 miles Deepak Gupta None None
    Vanderbilt University - Nashville, Tennessee 942.2 miles Deepak Gupta None None
    Mayo Clinic - Rochester, Minnesota 1,083.1 miles Barry Borlaug MD None None
    Mayo Clinic - Rochester, Minnesota 1,083.1 miles Barry Borlaug MD None None
    Mayo Clinic - Rochester, Minnesota 1,083.1 miles Barry Borlaug MD None None
    Mayo Clinic - Rochester, Minnesota 1,083.1 miles Barry Borlaug MD None None
    Mayo Clinic - Rochester, Minnesota 1,083.1 miles Barry Borlaug MD None None
    Minneapolis Heart Institute Foundation - Minneapolis, Minnesota 1,120.8 miles None None None
    Minneapolis Heart Institute Foundation - Minneapolis, Minnesota 1,120.8 miles None None None
    Minneapolis Heart Institute Foundation - Minneapolis, Minnesota 1,120.8 miles None None None
    Minneapolis Heart Institute Foundation - Minneapolis, Minnesota 1,120.8 miles None None None
    Iowa Heart Center - West Des Moines, Iowa 1,143.9 miles None None None
    Iowa Heart Center - West Des Moines, Iowa 1,143.9 miles None None None
    Iowa Heart Center - West Des Moines, Iowa 1,143.9 miles None None None
    Iowa Heart Center - West Des Moines, Iowa 1,143.9 miles None None None
    Sarasota Memorial Hospital - Sarasota, Florida 1,225.8 miles None None None
    St Lukes - Kansas City, Missouri 1,250.3 miles Anthony Magalski MD None None
    St Lukes - Kansas City, Missouri 1,250.3 miles Anthony Magalski MD None None
    St Lukes - Kansas City, Missouri 1,250.3 miles Anthony Magalski MD None None
    St Lukes - Kansas City, Missouri 1,250.3 miles Anthony Magalski MD None None
    St Lukes - Kansas City, Missouri 1,250.3 miles Anthony Magalski MD None None
    Tallahassee Research Institute Inc - Tallahassee, Florida 1,260.3 miles Wayne Batchelor MD None None
    Tallahassee Research Institute Inc - Tallahassee, Florida 1,260.3 miles Wayne Batchelor MD None None
    Tallahassee Research Institute Inc - Tallahassee, Florida 1,260.3 miles Wayne Batchelor MD None None
    Tallahassee Research Institute Inc - Tallahassee, Florida 1,260.3 miles Wayne Batchelor MD None None
    Tallahassee Research Institute Inc - Tallahassee, Florida 1,260.3 miles Wayne Batchelor MD None None
    Baptist Hospital of Miami - Miami, Florida 1,271.8 miles None None None
    CHI Nebraska Heart Institute - Lincoln, Nebraska 1,319.2 miles None None None
    CHI Nebraska Heart Institute - Lincoln, Nebraska 1,319.2 miles None None None
    CHI Nebraska Heart Institute - Lincoln, Nebraska 1,319.2 miles None None None
    Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Selim Krim MD None None
    Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Selim Krim MD None None
    Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Selim Krim MD None None
    Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Selim Krim MD None None
    Ochsner Clinic Foundation - New Orleans, Louisiana 1,363.3 miles Selim Krim MD None None
    Cardiovascular Institute of the South - Houma, Louisiana 1,407.3 miles Peter Fail MD None None
    Cardiovascular Institute of the South - Houma, Louisiana 1,407.3 miles Peter Fail MD None None
    Cardiovascular Institute of the South - Houma, Louisiana 1,407.3 miles Peter Fail MD None None
    Cardiovascular Institute of the South - Houma, Louisiana 1,407.3 miles Peter Fail MD None None
    Cardiovascular Institute of the South - Houma, Louisiana 1,407.3 miles Peter Fail MD None None
    Oklahoma Heart Hospital Research Foundation - Oklahoma City, Oklahoma 1,493.8 miles None None None
    Oklahoma Heart Hospital Research Foundation - Oklahoma City, Oklahoma 1,493.8 miles None None None
    Oklahoma Heart Hospital Research Foundation - Oklahoma City, Oklahoma 1,493.8 miles None None None
    Oklahoma Heart Hospital Research Foundation - Oklahoma City, Oklahoma 1,493.8 miles None None None
    Oklahoma Heart Hospital Research Foundation - Oklahoma City, Oklahoma 1,493.8 miles None None None
    The University of Texas Houston - Houston, Texas 1,609.9 miles None None None
    The University of Texas Houston - Houston, Texas 1,609.9 miles None None None
    The University of Texas Houston - Houston, Texas 1,609.9 miles None None None
    The University of Texas Houston - Houston, Texas 1,609.9 miles None None None
    The University of Texas Houston - Houston, Texas 1,609.9 miles None None None
    University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,766.9 miles None None None
    University of Texas Health Science Center at San Antonio - San Antonio, Texas 1,766.9 miles None None None
    Intermountain Medical Center - Murray, Utah 2,098.4 miles None None None
    Intermountain Medical Center - Murray, Utah 2,098.4 miles None None None
    Intermountain Medical Center - Murray, Utah 2,098.4 miles None None None
    Intermountain Medical Center - Murray, Utah 2,098.4 miles None None None
    St Patrick Hospital Providence - Missoula, Montana 2,111.5 miles None None None
    St Patrick Hospital Providence - Missoula, Montana 2,111.5 miles None None None
    St Patrick Hospital Providence - Missoula, Montana 2,111.5 miles None None None
    St Patrick Hospital Providence - Missoula, Montana 2,111.5 miles None None None
    St Patrick Hospital Providence - Missoula, Montana 2,111.5 miles None None None
    University of Arizona College of Medicine - Tucson, Arizona 2,281.0 miles Elizabeth Juneman MD None None
    University of Arizona College of Medicine - Tucson, Arizona 2,281.0 miles Elizabeth Juneman MD None None
    University of Arizona College of Medicine - Tucson, Arizona 2,281.0 miles Elizabeth Juneman MD None None
    University of Arizona College of Medicine - Tucson, Arizona 2,281.0 miles Elizabeth Juneman MD None None
    University of Arizona College of Medicine - Tucson, Arizona 2,281.0 miles Elizabeth Juneman MD None None
    Scripps Clinic - La Jolla, California 2,583.7 miles None None None
    Kaiser Permanente San Francisco Medical Center - San Francisco, California 2,698.0 miles None None None

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