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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSE Pulsed Field Ablation system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Failure-free rate at 12 months post index procedure | 12 monhts |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint | Composite of device- or procedure-related serious adverse events at early onset or chronic onset | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to the hospitals' standard of care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince Charles Hospital | Brisbane | Australia | ||||
| Fiona Stanley Hospital |
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| 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 | 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 |
| CHU Grenoble | Grenoble | France |
| Hopital Saint Philibert-Hospital | Lomme | France |
| Hopital Prive du Confluent SAS | Nantes | France |
| Clinique Ambroise Pare-Hospital | Neuilly | France |
| Centre Cardiologique du Nord | Saint-Denis | France |
| Clinique Pasteur Toulouse | Toulouse | France |
| Universitaetsklinikum Aachen (UKA) | Aachen | Germany |
| Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH | Dresden | Germany |
| Georg-August-Universitaet Goettingen | Göttingen | Germany |
| St Georg Asklepios | Hamburg | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | Germany |
| Staedisches Klinikum Karlsruhe | Karlsruhe | Germany |
| University Hospital of Muenster | Münster | Germany |
| Henry Dunant hospital | Athens | Greece |
| Onassis Cardiac Surgery Center | Athens | Greece |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Semmelweis University | Budapest | Hungary |
| Mater Private Hospital | Dublin | Ireland |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Az. Osp. Lancisi-Hospital | Ancona | Italy |
| Casa Di Cura 'Montevergine' S.P.A. | Mercogliano | Italy |
| Ospedale Rivoli | Rivoli | Italy |
| Ospedale Isola Tiberina Gemelli Isola | Roma | Italy |
| Ospedale San Bortolo de Vicenza | Vicenza | Italy |
| Institut Jantung Negara | Kuala Lumpur | Malaysia |
| Princesse Grace | Monaco | Monaco |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | Poland |
| Hospital de Santa Cruz | Carnaxide | Portugal |
| King Fahd Armed Forces Hospital | Jeddah | Saudi Arabia |
| Centro Especial Ramon y Cajal | Madrid | Spain |
| Clinica Universidad de Navarra | Pamplona | Spain |
| Hospital Universitario La Fe | Valencia | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain |
| Royal Papworth Hospital | Cambridge | United Kingdom |
| Liverpool Heart & Chest Hospital | Liverpool | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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