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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: FARAPULSE Pulsed Field Ablation system

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 1173

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Prince Charles Hospital
  • Murdoch, Australia
    • Fiona Stanley Hospital
  • Newcastle, Australia
    • John Hunter Hospital
• Austria
  • Vienna, Austria
    • Allgemeines Krankenhaus AKH
• Belgium
  • Bruges, Belgium
    • AZ Sint Jan Hospital
  • Hasselt, Belgium
    • Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
  • Liège, Belgium
    • CHR de la Citadelle
• Czechia
  • Brno, Czechia
    • Neuron Medical in Brno
  • České Budějovice, Czechia
    • Nemocnice Ceske Budejovice a.s.
• Finland
  • Tampere, Finland
    • Tays Heart Hospital
• France
  • Grenoble, France
    • CHU Grenoble
  • Lomme, France
    • Hopital Saint Philibert-Hospital
  • Nantes, France
    • Hopital Prive du Confluent SAS
  • Neuilly, France
    • Clinique Ambroise Pare-Hospital
  • Saint-Denis, France
    • Centre Cardiologique du Nord
  • Toulouse, France
    • Clinique Pasteur Toulouse
• Germany
  • Aachen, Germany
    • Universitaetsklinikum Aachen (UKA)
  • Dresden, Germany
    • Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
  • Göttingen, Germany
    • Georg-August-Universitaet Goettingen
  • Hamburg, Germany
    • St Georg Asklepios
  • Heidelberg, Germany
    • Universitaetsklinikum Heidelberg
  • Karlsruhe, Germany
    • Staedisches Klinikum Karlsruhe
  • Münster, Germany
    • University Hospital of Muenster
• Greece
  • Athens, Greece
    • Onassis Cardiac Surgery Center
  • Athens, Greece
    • Henry Dunant Hospital
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Hungary
  • Budapest, Hungary
    • Semmelweis University
• Ireland
  • Dublin, Ireland
    • Mater Private Hospital
• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
• Italy
  • Ancona, Italy
    • Az. Osp. Lancisi-Hospital
  • Mercogliano, Italy
    • Casa Di Cura 'Montevergine' S.P.A.
  • Rivoli, Italy
    • Ospedale Rivoli
  • Roma, Italy
    • Ospedale Isola Tiberina Gemelli Isola
  • Vicenza, Italy
    • Ospedale San Bortolo de Vicenza
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institut Jantung Negara
• Monaco
  • Monaco, Monaco
    • Princesse Grace
• Netherlands
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
• Poland
  • Warsaw, Poland
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
• Portugal
  • Carnaxide, Portugal
    • Hospital de Santa Cruz
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Fahd Armed Forces Hospital
• Spain
  • Madrid, Spain
    • Centro Especial Ramon y Cajal
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Valencia, Spain
    • Hospital Universitario la Fe
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa
• United Kingdom
  • Cambridge, United Kingdom
    • Royal Papworth Hospital
  • Liverpool, United Kingdom
    • Liverpool Heart & Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to the hospitals' standard of care

Description

Inclusion Criteria:

1. 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
2. Subjects who are willing and capable of providing informed consent
3. Subjects who are willing and capable of participating in all testing associated with this 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 informed consent specific to state and national law

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 Vascular Accident (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 aortic valvuloplasty
12. 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)
13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
14. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	Failure-free rate at 12 months post index procedure	12 monhts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint	Composite of device- or procedure-related serious adverse events at early onset or chronic onset	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Actual): October 21, 2025
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PF114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No