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FARAPULSE Workflow Assessment Registry

NCT ID: NCT06656884

Last Updated: 2025-12-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-06

Study Completion Date

2027-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Keywords

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Catheter Ablation Pulsed Field Ablation FARAPULSE Workflow Assessment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Prior Left Atrium Ablation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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A.o. Krankenhaus der Elisabethinen Linz

Linz, , Austria

Site Status RECRUITING

Ziekenhuis aan de Stroom, Middelheim

Antwerp, , Belgium

Site Status RECRUITING

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status RECRUITING

CHR de la Citadelle

Namur, , Belgium

Site Status RECRUITING

CHU de Bordeaux

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Hopital Saint Philibert

Lomme, , France

Site Status RECRUITING

CHRU Hopital Trousseau

Tours, , France

Site Status RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status NOT_YET_RECRUITING

Staedtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status RECRUITING

Munchen Klinik Bogenhausen

München, , Germany

Site Status RECRUITING

University Hospital of Muenster

Münster, , Germany

Site Status WITHDRAWN

Ippokrateio General Hospital of Athens

Athens, , Greece

Site Status RECRUITING

Mitera Hospital

Athens, , Greece

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, , Italy

Site Status RECRUITING

Ospedale Dell Angelo

Mestre, , Italy

Site Status RECRUITING

Azienda Ospedaliera San Gerardo

Monza, , Italy

Site Status RECRUITING

Ospedale di Rivoli

Rivoli, , Italy

Site Status RECRUITING

Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica

Vicenza, , Italy

Site Status RECRUITING

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

King Fahd Armed Forces Hospital

Jeddah, , Saudi Arabia

Site Status RECRUITING

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status RECRUITING

University Hospital Virgen Arrixaca

El Palmar, , Spain

Site Status RECRUITING

Hospital de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario Nuestra Senora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status RECRUITING

GHP Arytmi Center Stockholm

Stockholm, , Sweden

Site Status RECRUITING

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, , United Kingdom

Site Status WITHDRAWN

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status RECRUITING

Papworth Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

Glenfield Hospital

Leicester, , United Kingdom

Site Status RECRUITING

St. Georges Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Southampton University Hospital

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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Austria Belgium France Germany Greece Italy Netherlands Saudi Arabia Spain Sweden United Kingdom

Central Contacts

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Hanneke Rombouts

Role: CONTACT

Phone: 0032 480 69 00 65

Email: [email protected]

Facility Contacts

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Martin Martinek, MD

Role: primary

Michael Wolf

Role: primary

Maximo Rivero, MD

Role: primary

Jean Manuel Herzet, MD

Role: primary

Frederic Sacher, MD

Role: primary

Yves Guyomar, MD

Role: primary

Bertrand Pierre, MD

Role: primary

Obaida Rana, MD

Role: primary

Patrick Lugenbiel, MD

Role: primary

Kerstin Schmidt, MD

Role: primary

Ellen Hoffmann, MD

Role: primary

Konstantinos Tsioufis, MD

Role: primary

Stylianos Tzeis, MD

Role: primary

Matteo Bertini, MD

Role: primary

Sakis Themistoclakis, MD

Role: primary

Giovanni Rovaris, MD

Role: primary

Ruggero Maggio, MD

Role: primary

Antonio Rossillo, MD

Role: primary

Jonas De Jong, MD

Role: primary

Fayez Bokhari, MD

Role: primary

Enrique Rodriguez, MD

Role: primary

Pablo Penafiel, MD

Role: primary

Nuria Basterra, MD

Role: primary

Luis Alvarez-Acosta, MD

Role: primary

Fariborz Tabrizi, MD

Role: primary

Richard Balasubramaniam, MD

Role: primary

Claire Martin, MD

Role: primary

Riyaz Somani, MD

Role: primary

Anthony Li, MD

Role: primary

Moloy Das, MD

Role: primary

Waqas Ullah, MD

Role: primary

Other Identifiers

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PF117

Identifier Type: -

Identifier Source: org_study_id