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

Last updated: May 5, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Arrhythmia

Treatment

FARAPULSE Pulsed Field Ablation system

Clinical Study ID

NCT05501873
PF114
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system forcardiac 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 withthis 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 informedconsent specific to state and national law

Exclusion

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 VascularAccident (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 aorticvalvuloplasty

  12. Subjects with a contraindication to an invasive electrophysiology procedure whereinsertion or manipulation of a catheter in the cardiac chambers is deemed unsafe perphysician's medical judgement, such as, but not limited to, a recent previouscardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stentprocedure/unstable angina) and/or in patients with congenital heart disease wherethe underlying abnormality increases the risk of the ablation (e.g., severerotational 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 registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be brought to theattention of the sponsor to determine eligibility

Study Design

Total Participants: 1173
Treatment Group(s): 1
Primary Treatment: FARAPULSE Pulsed Field Ablation system
Phase:
Study Start date:
March 24, 2023
Estimated Completion Date:
August 15, 2027

Study Description

This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific).

Connect with a study center

  • Prince Charles Hospital

    Brisbane,
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch,
    Australia

    Site Not Available

  • John Hunter Hospital

    Newcastle,
    Australia

    Site Not Available

  • Allgemeines Krankenhaus AKH

    Vienna,
    Austria

    Site Not Available

  • AZ Sint Jan Hospital

    Brugge,
    Belgium

    Site Not Available

  • Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

    Hasselt,
    Belgium

    Site Not Available

  • CHR de la Citadelle

    Liège,
    Belgium

    Site Not Available

  • Neuron Medical in Brno

    Brno,
    Czechia

    Site Not Available

  • Nemocnice Ceske Budejovice a.s.

    České Budějovice,
    Czechia

    Site Not Available

  • Tays Heart Hospital

    Tampere,
    Finland

    Site Not Available

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • Hopital Saint Philibert-Hospital

    Lomme,
    France

    Site Not Available

  • Hopital Prive du Confluent SAS

    Nantes,
    France

    Site Not Available

  • Clinique Ambroise Pare-Hospital

    Neuilly,
    France

    Site Not Available

  • Centre Cardiologique du Nord

    Saint-Denis,
    France

    Site Not Available

  • Clinique Pasteur Toulouse

    Toulouse,
    France

    Site Not Available

  • Universitaetsklinikum Aachen (UKA)

    Aachen,
    Germany

    Site Not Available

  • Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH

    Dresden,
    Germany

    Site Not Available

  • Georg-August-Universitaet Goettingen

    Göttingen,
    Germany

    Site Not Available

  • St Georg Asklepios

    Hamburg,
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Staedisches Klinikum Karlsruhe

    Karlsruhe,
    Germany

    Site Not Available

  • University Hospital of Muenster

    Münster,
    Germany

    Site Not Available

  • Henry Dunant hospital

    Athens,
    Greece

    Site Not Available

  • Onassis Cardiac Surgery Center

    Athens,
    Greece

    Site Not Available

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Semmelweis University

    Budapest,
    Hungary

    Site Not Available

  • Mater Private Hospital

    Dublin,
    Ireland

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Az. Osp. Lancisi-Hospital

    Ancona,
    Italy

    Site Not Available

  • Casa Di Cura 'Montevergine' S.P.A.

    Mercogliano,
    Italy

    Site Not Available

  • Ospedale Rivoli

    Rivoli,
    Italy

    Site Not Available

  • Ospedale Isola Tiberina Gemelli Isola

    Roma,
    Italy

    Site Not Available

  • Ospedale San Bortolo de Vicenza

    Vicenza,
    Italy

    Site Not Available

  • Institut Jantung Negara

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Princesse Grace

    Monaco,
    Monaco

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw,
    Poland

    Site Not Available

  • Hospital de Santa Cruz

    Carnaxide,
    Portugal

    Site Not Available

  • King Fahd Armed Forces Hospital

    Jeddah,
    Saudi Arabia

    Site Not Available

  • Centro Especial Ramon y Cajal

    Madrid,
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Hospital Universitario La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital Clinico Universitario Lozano Blesa

    Zaragosa,
    Spain

    Site Not Available

  • Royal Papworth Hospital

    Cambridge,
    United Kingdom

    Site Not Available

  • Liverpool Heart & Chest Hospital

    Liverpool,
    United Kingdom

    Site Not Available

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