Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
NCT ID: NCT05501873
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1173 participants
OBSERVATIONAL
2023-03-24
2027-08-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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FARAPULSE Pulsed Field Ablation system
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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who are willing and capable of providing informed consent
3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
Exclusion Criteria
2. Subjects with a known or suspected atrial myxoma
3. Subjects with a myocardial infarction within 14 days prior to enrollment
4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
5. Subjects who do not tolerate anticoagulation therapy
6. Subjects with an active systemic infection \*
7. Subjects with a presence of atrial known thrombus \*
8. Subjects with a known inability to obtain vascular access
9. Subjects who are pregnant or planning to be pregnant
10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure/unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Other Identifiers
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PF114
Identifier Type: -
Identifier Source: org_study_id