REDUCE LAP-HF TRIAL II



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:3/16/2019
Start Date:June 1, 2017
End Date:July 2024
Contact:Jan Komtebedde, DVM
Email:jkomtebedde@corviamedical.com
Phone:978-654-6113

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A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure

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

Following supine bicycle exercise testing to assess eligibility, the eligible patients are
randomized to the treatment or control group.

All patients will be sedated, and both treatment and control arm patients will undergo
placement of a femoral venous access sheath after randomization.

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac
echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal
puncture and IASD System II implant procedure. Patients randomized to the control arm will
undergo ICE from the femoral vein or TEE for examination of the atrial septum and left
atrium.

Patients will be evaluated at pre-specified time intervals and followed for 5 years.

All patients will be unblinded after the 24 month follow up visit. Patients randomized to the
control arm will be allowed to cross-over to the treatment arm at ≥ 24 months post-control
procedure provided patient selection criteria are met at that time. Cross-over patients will
then be followed for 5 years after cross-over.

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 AND

- NYHA class II with a history of > NYHA class II; OR 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 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

- Advanced 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 likely to require
intervention

- Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
We found this trial at
62
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Atlanta, Georgia 30309
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Boston, Massachusetts
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Camperdown, New South Wales
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlottesville, Virginia 22903
(434) 924-0311
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303 East Superior Street
Chicago, Illinois 60611
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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2123 Auburn Avenue
Cincinnati, Ohio 45219
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180 East Broad Street
Columbus, Ohio 43214
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Delray Beach, Florida 33431
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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1000 Central Street
Evanston, Illinois 60201
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1 Hamilton Health Place
Hamilton, New Jersey 08690
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Houma, Louisiana 70360
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Houston, Texas 77030
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
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Kansas City, Missouri 64111
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
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La Jolla, California 92120
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
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Little Rock, Arkansas 72211
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Littleton, Colorado 80120
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Los Angeles, California 90095
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
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Minneapolis, Minnesota 55407
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
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5121 S Cottonwood St
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2201 West End Ave
Nashville, Tennessee 37232
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New Haven, Connecticut 6520
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New Orleans, Louisiana 70121
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3451 Walnut St
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Poughkeepsie, New York 12601
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1250 E. Marshall St.
Richmond, Virginia 23298
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Rochester, Minnesota 55905
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1700 S Tamiami Trail
Sarasota, Florida 34239
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5300 Tallman Ave NW
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Tallahassee, Florida 32308
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