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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
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

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Allgemeines Krankenhaus AKH
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ViennaAustriaUnknown status
Prince Charles Hospital
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BrisbaneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
John Hunter Hospital
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NewcastleAustraliaUnknown status
AZ Sint-Jan Hospital
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BrugesBelgiumUnknown status
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
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HasseltBelgiumUnknown status
CHR de la Citadelle
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LiègeBelgiumUnknown status
Neuron Medical in Brno
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BrnoCzechiaUnknown status
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaUnknown status
Universitaetsklinikum Aachen (UKA)
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AachenGermanyUnknown status
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
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DresdenGermanyUnknown status
Georg-August-Universitaet Goettingen
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GöttingenGermanyUnknown status
St Georg Asklepios
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HamburgGermanyUnknown status
Universitaetsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Staedisches Klinikum Karlsruhe
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KarlsruheGermanyUnknown status
University Hospital of Muenster
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MünsterGermanyUnknown status
Centro Especial Ramon y Cajal
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MadridSpainUnknown status
Clínica Universidad de navarra
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PamplonaSpainUnknown status
Hospital Universitario la Fe
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ValenciaSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status
Tays Heart Hospital
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TampereFinlandUnknown status
Chu Grenoble
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GrenobleFranceUnknown status
Hopital Saint Philibert-Hospital
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LommeFranceUnknown status
Hôpital privé du Confluent SAS
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NantesFranceUnknown status
Clinique Ambroise Pare-Hospital
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NeuillyFranceUnknown status
Centre Cardiologique du Nord
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Saint-DenisFranceUnknown status
Clinique Pasteur - Toulouse
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ToulouseFranceUnknown status
Royal Papworth Hospital
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CambridgeUnited KingdomUnknown status
Liverpool Heart & Chest Hospital
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LiverpoolUnited KingdomUnknown status
Onassis Cardiac Surgery Center
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AthensGreeceUnknown status
Henry Dunant Hospital
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AthensGreeceUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Semmelweis University
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BudapestHungaryUnknown status
Mater Private Hospital
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DublinIrelandUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Az. Osp. Lancisi-Hospital
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AnconaItalyUnknown status
Casa Di Cura 'Montevergine' S.P.A.
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MercoglianoItalyUnknown status
Ospedale Rivoli
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RivoliItalyUnknown status
Ospedale Isola Tiberina - Gemelli Isola
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RomaItalyUnknown status
Ospedale San Bortolo de Vicenza
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VicenzaItalyUnknown status
Princesse Grace
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MonacoMonacoUnknown status
Institut Jantung Negara
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Kuala LumpurMalaysiaUnknown status
Catharina Ziekenhuis
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EindhovenNetherlandsUnknown status
St. Antonius Ziekenhuis
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NieuwegeinNetherlandsUnknown status
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandUnknown status
Hospital de Santa Cruz
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CarnaxidePortugalUnknown status
King Fahd Armed Forces Hospital
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JeddahSaudi ArabiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.