355
Participants
Start Date
June 29, 2020
Primary Completion Date
July 1, 2022
Study Completion Date
July 1, 2022
TactiFlex SE
Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
TactiFlex SE - High Standard Power
Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Westmead Hospital, Westmead
Erasmus MC - Thoraxcenter, Rotterdam
Monash Medical Centre, Clayton
A. ö. Krankenhaus der Elisabethinen Linz, Linz
The Prince Charles Hospital, Chermside
Wesley Private Hospital, Auchenflower
Herzzentrum Leipzig GmbH, Leipzig
Royal Adelaide Hospital, Adelaide
New York University Hospital, New York
New York-Presbyterian/Columbia University Medical Center, New York
Taipei Veterans General Hospital (VGH), Taipei
IKEM Prague, Prague
Hospital of the University of Pennsylvania, Philadelphia
Ospedale San Raffaele, Milan
NC Heart & Vascular Research, Raleigh
Medical University of South Carolina, Charleston
Piedmont Athens Regional Medical Center, Athens
Herz-und Diabetes Zentrum NRW, Bad Oeynhausen
AdventHealth Orlando, Orlando
Affinity Cardiovascular Specialists, LLC, Birmingham
North Mississippi Medical Center, Tupelo
Jackson Heart Clinic, Jackson
Ohio State University, Columbus
The Cleveland Clinic Foundation, Cleveland
St. Vincent Hospital, Indianapolis
Providence Hospital, Southfield
Iowa Heart Center, West Des Moines
Kansas City Cardiac Arrhythmia Research Foundation, Overland Park
Ochsner Medical Center, New Orleans
Arkansas Heart Hospital, Little Rock
St. Bernards Medical Center, Jonesboro
The Heart Hospital Baylor Plano, Plano
Memorial Hermann Hospital, Houston
Texas Cardiac Arrhythmia Research Foundation, Austin
South Denver Cardiology Associates PC, Littleton
St. Luke's Regional Medical Center, Boise
Kootenai Heart Clinics, Coeur d'Alene
Scripps Health, La Jolla
University of California at San Diego (UCSD) Medical Center, San Diego
Mills-Peninsula Medical Center, Burlingame
Franciscan Heart & Vascular Associates, Tacoma
Massachusetts General Hospital, Boston
Kingston General Hospital, Kingston
Sunnybrook Health Sciences Centre, Toronto
Prince of Wales Hospital, Hong Kong
Lead Sponsor
Abbott Medical Devices
INDUSTRY