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REDUCE LAP-HF TRIAL II
Sponsor: Corvia Medical
Summary
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
Official title: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
608
Start Date
2017-06-01
Completion Date
2026-09
Last Updated
2023-02-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (91)
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Kaiser Permanente San Diego
La Jolla, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Yale University
New Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Evanston Northshore Healthcare
Evanston, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Tufts New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Hackensack University Medical Center
Hamilton, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
Christ Hospital Ohio Heart and Vascular Institute
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University College of Medicine
Columbus, Ohio, United States
Ohio Health
Columbus, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor University Medical Center, Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Concord Hospital
Camperdown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
St. Vincent Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Medizinische Universität Graz
Graz, Austria
OLVZ Aalst
Aalst, Belgium
Az Sint-Jan Brugge
Bruges, Belgium
Hamilton Health Sciences
Hamilton, Ontario, Canada
University Hospital Center, Zagreb
Zagreb, Croatia
Rigshospitalet
Copenhagen, Denmark
CHU de Dijon
Dijon, France
CHU de Nantes
Nantes, France
Hôpital Bichat
Paris, France
Hôpital La Pitié Salpétrière
Paris, France
CHU de Rennes
Rennes, France
CHU de Rouen
Rouen, France
Kerckhoff Klinik
Bad Nauheim, Germany
Charite Universitatsmedizin Berlin
Berlin, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
Universitatklinikum Duseldorf
Düsseldorf, Germany
Heart Center Freiburg University
Freiburg im Breisgau, Germany
Georg-August-Universitat
Göttingen, Germany
Cardiologicum CRC
Hamburg, Germany
UKE Hamburg
Hamburg, Germany
University of Heidelberg
Heidelberg, Germany
Heart Center of the University of Leipzig
Leipzig, Germany
Klinikum der Universität Munchen
Munich, Germany
University of Milano
Milan, Italy
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kyushu University Hospital
Fukuoka, Japan
The Hospital of Hyogo College of Medicine
Hyōgo, Japan
Nara Medical University Hospital
Nara, Japan
National Cerebral and Cardiovascular Center
Osaka, Japan
Osaka University Hospital
Osaka, Japan
The University of Tokyo Hospital
Tokyo, Japan
Tottori University Hospital
Tottori, Japan
Toyama University Hospital
Toyama, Japan
VU University Medical Center
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
Maastricht UMC Hart & Vaat Centrum
Maastricht, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Fourth Military Hospital
Wroclaw, Poland
Hospital Clinic Barcelona
Barcelona, Spain
Golden Jubilee Hospital
Glasgow, United Kingdom
Guys & St Thomas NHS Foundation Trust
London, United Kingdom