IASD System II implantintra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
IASD System II implant: The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE): intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
Study summary
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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 3 years)
* Elevated PCWP 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
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
Primary outcome measure(s)
Composite Primary Endpoint — Up to 24 months The primary endpoint is the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
Trial sites (91)
Facility
City
Region
Status
Arizona Cardiovascular Research Center
Phoenix
Arizona
University of Arizona College of Medicine
Tucson
Arizona
Scripps Clinic
La Jolla
California
Kaiser Permanente San Diego
La Jolla
California
Kaiser Permanente San Francisco Medical Center
San Francisco
California
South Denver Cardiology Associates
Littleton
Colorado
Yale University
New Haven
Connecticut
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
Holy Cross Hospital
Fort Lauderdale
Florida
Sarasota Memorial Hospital
Sarasota
Florida
Tallahassee Research Institute, Inc.
Tallahassee
Florida
Cleveland Clinic Florida
Weston
Florida
Northwestern University
Chicago
Illinois
University of Chicago Medical Center
Chicago
Illinois
Evanston Northshore Healthcare
Evanston
Illinois
Cardiovascular Institute of the South
Houma
Louisiana
Ochsner Clinic Foundation
New Orleans
Louisiana
Tufts New England Medical Center
Boston
Massachusetts
Massachusetts General Hospital
Boston
Massachusetts
University of Michigan Health System
Ann Arbor
Michigan
Minneapolis Heart Institute Foundation
Minneapolis
Minnesota
Mayo Clinic
Rochester
Minnesota
St. Louis Heart and Vascular
St Louis
Missouri
Hackensack University Medical Center
Hamilton
New Jersey
Morristown Memorial Hospital
Morristown
New Jersey
Duke University Medical Center
Durham
North Carolina
Wake Forest
Winston-Salem
North Carolina
Christ Hospital Ohio Heart and Vascular Institute
Cincinnati
Ohio
Cleveland Clinic
Cleveland
Ohio
Ohio State University College of Medicine
Columbus
Ohio
Ohio Health
Columbus
Ohio
Lancaster General Hospital
Lancaster
Pennsylvania
University of Pennsylvania
Philadelphia
Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
Vanderbilt University
Nashville
Tennessee
Baylor University Medical Center, Dallas
Dallas
Texas
Baylor College of Medicine
Houston
Texas
Houston Methodist Hospital
Houston
Texas
University of Texas Health Science Center at San Antonio
San Antonio
Texas
+ 51 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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