450
Participants
Start Date
May 9, 2022
Primary Completion Date
November 30, 2025
Study Completion Date
October 26, 2026
Investigational PFO Closure Device
Occlutech Flex II PFO Closure Device
Standard of Care PFO Closure Device
Amplatzer PFO Occluder and Gore Cardioform PFO Occluder
Rigshospitalet Copenhagen, Copenhagen
UPMC Presbyterian, Pittsburgh
Medstar Washington Hospital Center, Washington D.C.
Universitaetsklinikum Hamburg-Eppendorf, Hamburg
Asklepios Klinik Altona Hamburg, Hamburg
University Heart Center Lübeck, Lübeck
CHU Toulouse Rangueil, Toulouse
Vanderbilt Medical Center, Nashville
CHU Grenoble Alpes, La Tronche
University of Louisville, Louisville
The Ohio State University, Columbus
Ohio Health Research Institute, Columbus
University Hospitals Cleveland Medical Center, Cleveland
University of Michigan, Ann Arbor
Essentia Health, Duluth
CardioVasculäre Centrum Frankfurt, Frankfurt
Rush University Medical Center, Chicago
OSF Saint Francis Medical Center, Peoria
University of Nebraska Medical Center, Omaha
Oklahoma Heart Hospital, Oklahoma City
HCA Houston Healthcare Medical Center, Houston
University of Texas Health Science Center at Houston, Houston
South Denver Cardiology Associates, Littleton
Colorado Heart and Vascular PC / St. Anthony Hospital, Lakewood
Arizona Cardiovascular Research Center, Phoenix
Hôpital Privé Jacques Cartier, Massy
Los Robles Medical Center, Thousand Oaks
Stanford University Medical Center, Stanford
Oregon Health & Science University, Portland
MaineHealth, Portland
Tufts New England Medical Center, Boston
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Baystate Medical Center, Springfield
The Valley Hospital, Paramus
University of Alberta Mazankowski Heart Institute, Edmonton
Vancouver General Hospital, Vancouver
Toronto General Hospital, Toronto
Centre Hospitalier de l'Université de Montreal (CHUM), Montreal
Institut de Cardiologie de Montréal, Montreal
Aarhus University Hospital, Aarhus
Heart and Lung Center, Helsinki University Hospital, Helsinki
Universitätsklinik Heidelberg, Heidelberg
Amsterdam University Medical Center, Amsterdam
Erasmus University Medical Centre, Rotterdam
University Hospitals Sussex, Brighton
Royal Victoria Hospital, Belfast
Ottawa Heart Institute, Ottawa
Lead Sponsor
Occlutech International AB
INDUSTRY