NCT05501873Active, not recruiting
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1173 (actual)
- First submitted
- 12 Aug 2022
- Start date
- 24 Mar 2023
- Primary completion date
- 21 Oct 2025
- Lead sponsor
- Boston Scientific Corporation
- Diseases
- Atrial fibrillation
- NCT number
- NCT05501873
What you commit to
- Study type: Observational
- Participants enrolled: 1173
- From 24 Mar 2023 to the primary completion date, 21 Oct 2025
- 48 sites in 21 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with a myocardial infarction within 14 days prior to enrollment
- Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
- Subjects who do not tolerate anticoagulation therapy
- 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)
Other illness
- Subjects with an active systemic infection \*
- Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
Other
- Subjects with a current interatrial baffle or patch
- Subjects with a known or suspected atrial myxoma
- Subjects with a presence of atrial known thrombus \*
- Subjects with a known inability to obtain vascular access
- Subjects who are pregnant or planning to be pregnant
- Subjects with a life expectancy of ≤ 1 year per investigator's opinion
- 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
Who the study is looking for
- 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
- Subjects who are willing and capable of providing informed consent
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Allgemeines Krankenhaus AKH Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Prince Charles Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| John Hunter Hospital Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| AZ Sint-Jan Hospital Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| CHR de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Neuron Medical in Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Unknown status |
| Universitaetsklinikum Aachen (UKA) Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Georg-August-Universitaet Goettingen Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| St Georg Asklepios Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Staedisches Klinikum Karlsruhe Coordinator of this site? Confirm its status | Karlsruhe | Germany | Unknown status |
| University Hospital of Muenster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Centro Especial Ramon y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Tays Heart Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
| Chu Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hopital Saint Philibert-Hospital Coordinator of this site? Confirm its status | Lomme | France | Unknown status |
| Hôpital privé du Confluent SAS Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Clinique Ambroise Pare-Hospital Coordinator of this site? Confirm its status | Neuilly | France | Unknown status |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Clinique Pasteur - Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Royal Papworth Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Liverpool Heart & Chest Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Onassis Cardiac Surgery Center Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Henry Dunant Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Mater Private Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Az. Osp. Lancisi-Hospital Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Casa Di Cura 'Montevergine' S.P.A. Coordinator of this site? Confirm its status | Mercogliano | Italy | Unknown status |
| Ospedale Rivoli Coordinator of this site? Confirm its status | Rivoli | Italy | Unknown status |
| Ospedale Isola Tiberina - Gemelli Isola Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale San Bortolo de Vicenza Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
| Princesse Grace Coordinator of this site? Confirm its status | Monaco | Monaco | Unknown status |
| Institut Jantung Negara Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Hospital de Santa Cruz Coordinator of this site? Confirm its status | Carnaxide | Portugal | Unknown status |
| King Fahd Armed Forces Hospital Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.