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NCT06656884Active, not recruiting

FARAPULSE Workflow Assessment Registry

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters. The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
524 (actual)
First submitted
21 Oct 2024
Start date
6 May 2025
Primary completion date
15 Feb 2027
Lead sponsor
Boston Scientific Corporation
NCT number
NCT06656884

What you commit to

  • Study type: Observational
  • Participants enrolled: 524
  • From 6 May 2025 to the primary completion date, 15 Feb 2027
  • 28 sites in 10 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

  • Prior Left Atrium Ablation

Other

  • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study

Who the study is looking for

  • Subjects are prospectively planned and 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 to this Registry 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 (28)

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

SiteCityCountrySite status
A. ö. Krankenhaus der Elisabethinen Linz
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LinzAustriaUnknown status
Ziekenhuis aan de Stroom, Middelheim
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AntwerpBelgiumUnknown status
Ziekenhuis Oost-Limburg
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GenkBelgiumUnknown status
CHR de la Citadelle
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NamurBelgiumUnknown status
Universitaetsklinikum Dusseldorf
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DüsseldorfGermanyUnknown status
Staedtisches Klinikum Karlsruhe
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KarlsruheGermanyUnknown status
Munchen Klinik Bogenhausen
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MünchenGermanyUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
University Hospital Virgen Arrixaca
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El PalmarSpainUnknown status
Hospital de Navarra
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PamplonaSpainUnknown status
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainUnknown status
CHU de Bordeaux
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BordeauxFranceUnknown status
Hopital Saint Philibert
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LommeFranceUnknown status
CHRU Hopital Trousseau
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ToursFranceUnknown status
Royal Bournemouth Hospital
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BournemouthUnited KingdomUnknown status
Papworth Hospital
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CambridgeUnited KingdomUnknown status
Glenfield Hospital
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LeicesterUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Southampton University Hospital
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SouthamptonUnited KingdomUnknown status
Mitera Hospital
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AthensGreeceUnknown status
Ippokrateio General Hospital of Athens
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AthensGreeceUnknown status
Azienda Ospedaliero Universitaria di Ferrara
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FerraraItalyUnknown status
Ospedale dell'Angelo
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MestreItalyUnknown status
Azienda Ospedaliera San Gerardo
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MonzaItalyUnknown status
Ospedale di Rivoli
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RivoliItalyUnknown status
Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica
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VicenzaItalyUnknown status
King Fahd Armed Forces Hospital
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JeddahSaudi ArabiaUnknown status
GHP Arytmi Center Stockholm
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StockholmSwedenUnknown status

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