Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

NAActive, not recruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

May 9, 2022

Primary Completion Date

November 30, 2025

Study Completion Date

October 26, 2026

Conditions
StrokePatent Foramen OvalePFO
Interventions
DEVICE

Investigational PFO Closure Device

Occlutech Flex II PFO Closure Device

DEVICE

Standard of Care PFO Closure Device

Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Trial Locations (48)

2100

Rigshospitalet Copenhagen, Copenhagen

15213

UPMC Presbyterian, Pittsburgh

20010

Medstar Washington Hospital Center, Washington D.C.

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

22763

Asklepios Klinik Altona Hamburg, Hamburg

23538

University Heart Center Lübeck, Lübeck

31400

CHU Toulouse Rangueil, Toulouse

37232

Vanderbilt Medical Center, Nashville

38700

CHU Grenoble Alpes, La Tronche

40202

University of Louisville, Louisville

43210

The Ohio State University, Columbus

43214

Ohio Health Research Institute, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

48109

University of Michigan, Ann Arbor

55804

Essentia Health, Duluth

60389

CardioVasculäre Centrum Frankfurt, Frankfurt

60612

Rush University Medical Center, Chicago

61637

OSF Saint Francis Medical Center, Peoria

68198

University of Nebraska Medical Center, Omaha

73120

Oklahoma Heart Hospital, Oklahoma City

77004

HCA Houston Healthcare Medical Center, Houston

77030

University of Texas Health Science Center at Houston, Houston

80120

South Denver Cardiology Associates, Littleton

80228

Colorado Heart and Vascular PC / St. Anthony Hospital, Lakewood

85016

Arizona Cardiovascular Research Center, Phoenix

91300

Hôpital Privé Jacques Cartier, Massy

91360

Los Robles Medical Center, Thousand Oaks

94305

Stanford University Medical Center, Stanford

97239

Oregon Health & Science University, Portland

04102

MaineHealth, Portland

02111

Tufts New England Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01199

Baystate Medical Center, Springfield

07652

The Valley Hospital, Paramus

Unknown

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

K1Y 4W7

Ottawa Heart Institute, Ottawa

Sponsors
All Listed Sponsors
lead

Occlutech International AB

INDUSTRY