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.
Study Type
OBSERVATIONAL
Enrollment
550
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.
Allgemeines Krankenhaus AKH
Vienna, Austria
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
...and 12 more locations
Primary Safety Endpoint
The Primary Safety Endpoint is defined as the rate of device or procedure related serious adverse events following the index procedure through the 12 Month Follow-up
Time frame: 12 months
Primary effectiveness Endpoint
The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success
Time frame: 12 Months
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