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Clinical Trials in the UK / NCT05501873
Active, not recruiting Observational

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

NCT05501873 · tracked via the Priya Life Science UK tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2023-03-24
Last updated
2026-08-19

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

FARAPULSE Pulsed Field Ablation system

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care 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: 1. Subjects with a current interatrial baffle or patch 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

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
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

+ 8 more sites — see the full list on the official registry below.

More Boston Scientific Corporation trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05501873 on ClinicalTrials.gov ↗ ← All trials in the UK