608
Participants
Start Date
June 1, 2017
Primary Completion Date
July 29, 2021
Study Completion Date
September 30, 2026
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.
St. Vincent Hospital, Sydney
Concord Hospital, Camperdown
Royal Prince Alfred Hospital, Camperdown
John Hunter Hospital, Newcastle
The Alfred Hospital, Melbourne
The Prince Charles Hospital, Brisbane
UPMC Presbyterian Hospital, Pittsburgh
Lancaster General Hospital, Lancaster
University of Pennsylvania, Philadelphia
Medstar Washington Hospital Center, Washington D.C.
University of Virginia, Charlottesville
Virginia Commonwealth University Medical Center, Richmond
Wake Forest, Winston-Salem
Duke University Medical Center, Durham
Medical University of South Carolina, Charleston
Tallahassee Research Institute, Inc., Tallahassee
Holy Cross Hospital, Fort Lauderdale
Cleveland Clinic Florida, Weston
Sarasota Memorial Hospital, Sarasota
Vanderbilt University, Nashville
University of Michigan Health System, Ann Arbor
Ohio State University College of Medicine, Columbus
Ohio Health, Columbus
Cleveland Clinic, Cleveland
Christ Hospital Ohio Heart and Vascular Institute, Cincinnati
Minneapolis Heart Institute Foundation, Minneapolis
Mayo Clinic, Rochester
Evanston Northshore Healthcare, Evanston
Northwestern University, Chicago
University of Chicago Medical Center, Chicago
St. Louis Heart and Vascular, St Louis
Ochsner Clinic Foundation, New Orleans
Cardiovascular Institute of the South, Houma
Baylor University Medical Center, Dallas, Dallas
Baylor College of Medicine, Houston
Houston Methodist Hospital, Houston
University of Texas Health Science Center at San Antonio, San Antonio
South Denver Cardiology Associates, Littleton
University of Utah Medical Center, Salt Lake City
Intermountain Medical Center, Murray
Arizona Cardiovascular Research Center, Phoenix
University of Arizona College of Medicine, Tucson
Scripps Clinic, La Jolla
Kaiser Permanente San Diego, La Jolla
Kaiser Permanente San Francisco Medical Center, San Francisco
Yale University, New Haven
Tufts New England Medical Center, Boston
Massachusetts General Hospital, Boston
Hackensack University Medical Center, Hamilton
Morristown Memorial Hospital, Morristown
Medizinische Universität Graz, Graz
OLVZ Aalst, Aalst
Az Sint-Jan Brugge, Bruges
Hamilton Health Sciences, Hamilton
University Hospital Center, Zagreb, Zagreb
Rigshospitalet, Copenhagen
CHU de Dijon, Dijon
CHU de Nantes, Nantes
Hôpital Bichat, Paris
Hôpital La Pitié Salpétrière, Paris
CHU de Rennes, Rennes
CHU de Rouen, Rouen
Kerckhoff Klinik, Bad Nauheim
Charite Universitatsmedizin Berlin, Berlin
Unfallkrankenhaus Berlin, Berlin
Universitatklinikum Duseldorf, Düsseldorf
Heart Center Freiburg University, Freiburg im Breisgau
Georg-August-Universitat, Göttingen
Cardiologicum CRC, Hamburg
UKE Hamburg, Hamburg
University of Heidelberg, Heidelberg
Heart Center of the University of Leipzig, Leipzig
Klinikum der Universität Munchen, Munich
University of Milano, Milan
Hokkaido University Hospital, Sapporo
Kyushu University Hospital, Fukuoka
The Hospital of Hyogo College of Medicine, Hyōgo
Nara Medical University Hospital, Nara
National Cerebral and Cardiovascular Center, Osaka
Osaka University Hospital, Osaka
The University of Tokyo Hospital, Tokyo
Tottori University Hospital, Tottori
Toyama University Hospital, Toyama
VU University Medical Center, Amsterdam
UMC Groningen, Groningen
Maastricht UMC Hart & Vaat Centrum, Maastricht
St Antonius Ziekenhuis, Nieuwegein
Fourth Military Hospital, Wroclaw
Hospital Clinic Barcelona, Barcelona
Golden Jubilee Hospital, Glasgow
Guys & St Thomas NHS Foundation Trust, London
Lead Sponsor
Corvia Medical
INDUSTRY