The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.
This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific).
Study Type
OBSERVATIONAL
Enrollment
1,173
Any subject who has signed the informed consent and for whom the FARAPULSE Pulsed Field Ablation system has been inserted into the body, and pulsed field ablation treatment has been received, are assigned to the treatment group.
Prince Charles Hospital
Brisbane, Australia
Fiona Stanley Hospital
Murdoch, Australia
John Hunter Hospital
Newcastle, Australia
Allgemeines Krankenhaus AKH
Vienna, Austria
AZ Sint Jan Hospital
Bruges, Belgium
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Primary Effectiveness Endpoint
Failure-free rate at 12 months post index procedure
Time frame: 12 monhts
Safety endpoint
Composite of device- or procedure-related serious adverse events at early onset or chronic onset
Time frame: 12 months
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Hasselt, Belgium
CHR de la Citadelle
Liège, Belgium
Neuron Medical in Brno
Brno, Czechia
Nemocnice Ceske Budejovice a.s.
České Budějovice, Czechia
Tays Heart Hospital
Tampere, Finland
...and 38 more locations