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A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
Sponsor: Boston Scientific Corporation
Summary
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2025-07-30
Completion Date
2027-08-01
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
FARAPULSE Pulsed Field Ablation System
Subjects who have provided written informed consent are considered enrolled. Subjects who have received ablation treatment with the FARAPULSE™ System are assigned to the 'TREATMENT' group.
Locations (32)
Allgemeines Krankenhaus AKH
Vienna, Austria
Klinicki bolnicki centar Zagreb
Zagreb, Croatia
CHRU de Clermont-Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
Hospital de la Pitie-Salpetriere
Paris, France
Hospital Europeen Georges-Pompidou (HEGP)
Paris, France
Centre Cardiologique du Nord
Saint-Denis, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
Clinique Pasteur
Toulouse, France
Vivantes Klinikum Am Urban
Berlin, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, Germany
Asklepios Klinik Saint Georg
Hamburg, Germany
Henry Dunant Hospital Center
Athens, Greece
Ippokrateio General Hospital
Thessaloniki, Greece
Ippokrateio General Hospital
Thessaloniki, Greece
Mater Private Hospital
Dublin, Ireland
Maria Cecilia Hospital
Cotignola, Italy
Clinica Montevergine
Mercogliano, Italy
Ospedale Civile Di Piacenza
Piacenza, Italy
Sheikh Jaber Al Ahmad Hospital
Kuwait City, Kuwait
Centre Hospitalier Princesse Grace
Monaco, Monaco
Eramus MC- University Medical Center
Rotterdam, Netherlands
Isala Klinieken
Zwolle, Netherlands
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
Uniwersytecki Szpital Kliniczny Wrocławiu
Wroclaw, Poland
National Guard Hospital
Riyadh, Saudi Arabia
Hospital de Basurto
Bilbao, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Cardiocentro Ticino
Lugano, Switzerland
University Hospital Zurich
Zurich, Switzerland
Cleveland Clinic London
London, United Kingdom