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FARAPULSE Workflow Assessment Registry
Sponsor: Boston Scientific Corporation
Summary
The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters. The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
524
Start Date
2025-05-06
Completion Date
2027-02-15
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Locations (28)
A.o. Krankenhaus der Elisabethinen Linz
Linz, Austria
Ziekenhuis aan de Stroom, Middelheim
Antwerp, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
CHR de la Citadelle
Namur, Belgium
CHU de Bordeaux
Bordeaux, France
Hopital Saint Philibert
Lomme, France
CHRU Hopital Trousseau
Tours, France
Universitaetsklinikum Dusseldorf
Düsseldorf, Germany
Staedtisches Klinikum Karlsruhe
Karlsruhe, Germany
Munchen Klinik Bogenhausen
München, Germany
Ippokrateio General Hospital of Athens
Athens, Greece
Mitera Hospital
Athens, Greece
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Ospedale Dell Angelo
Mestre, Italy
Azienda Ospedaliera San Gerardo
Monza, Italy
Ospedale di Rivoli
Rivoli, Italy
Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica
Vicenza, Italy
King Fahd Armed Forces Hospital
Jeddah, Saudi Arabia
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
University Hospital Virgen Arrixaca
El Palmar, Spain
Hospital de Navarra
Pamplona, Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Spain
GHP Arytmi Center Stockholm
Stockholm, Sweden
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Southampton University Hospital
Southampton, United Kingdom