FARAPULSE Workflow Assessment Registry (FARAWAY)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation (AF)

• Study Type: Observational
• Enrollment (Actual): 524

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • A.o. Krankenhaus der Elisabethinen Linz
• Belgium
  • Antwerp, Belgium
    • Ziekenhuis aan de Stroom, Middelheim
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg
  • Namur, Belgium
    • CHR de la Citadelle
• France
  • Bordeaux, France
    • CHU de Bordeaux
  • Lomme, France
    • Hôpital Saint Philibert
  • Tours, France
    • CHRU Hopital Trousseau
• Germany
  • Düsseldorf, Germany
    • Universitaetsklinikum Dusseldorf
  • Karlsruhe, Germany
    • Staedtisches Klinikum Karlsruhe
  • München, Germany
    • Munchen Klinik Bogenhausen
• Greece
  • Athens, Greece
    • Ippokrateio General Hospital of Athens
  • Athens, Greece
    • Mitera Hospital
• Italy
  • Ferrara, Italy
    • Azienda Ospedaliero-Universitaria di Ferrara
  • Mestre, Italy
    • Ospedale Dell Angelo
  • Monza, Italy
    • Azienda Ospedaliera San Gerardo
  • Rivoli, Italy
    • Ospedale di Rivoli
  • Vicenza, Italy
    • Ospedale San Bortolo di Vicenza Azienda ULSS 8 Berica
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Fahd Armed Forces Hospital
• Spain
  • Barcelona, Spain
    • Hospital De La Santa Creu I Sant Pau
  • El Palmar, Spain
    • University Hospital Virgen Arrixaca
  • Pamplona, Spain
    • Hospital De Navarra
  • Santa Cruz de Tenerife, Spain
    • Hospital Universitario Nuestra Señora de Candelaria
• Sweden
  • Stockholm, Sweden
    • GHP Arytmi Center Stockholm
• United Kingdom
  • Bournemouth, United Kingdom
    • Royal Bournemouth Hospital
  • Cambridge, United Kingdom
    • Papworth Hospital
  • Leicester, United Kingdom
    • Glenfield Hospital
  • Newcastle upon Tyne, United Kingdom
    • Freeman Hospital
  • Southampton, United Kingdom
    • Southampton University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of patient demographics with Index procedure Workflow-related variables	Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management	Index Procedure
Association of safety parameters with Index procedure Workflow-related variables	Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula) will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management	12 months
Association of effectiveness parameters with Index procedure Workflow-related variables	Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters will be compared with different index procedure workflow related variables such as pre-procedural imaging, method and location of transseptal access, intracardiac electro-anatomical mapping, imaging techniques, anesthesia/sedation technique, ablation settings, dosing strategy, lesion sets and general procedure management	12 months
Association of patient demographics with effectiveness parameters	Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Acute and long-term (freedom from AF episodes and freedom from intervention for AF/AFL/AT) Effectiveness parameters	12 months
Association of patient demographics with safety parameters	Patient demographics such as age (years), gender, BMI (kg/m²), different comorbidities, LA Volume (ml), PV anatomy, AF type, pre-procedural AF management) will be compared with Safety parameters such as device or procedure related serious adverse events (within 7 days onset date) Death; Myocardial Infarction; Stroke; TIA; Peripheral or Organ Thromboembolism; Pulmonary Edema; Unresolved Phrenic Nerve Palsy/Paresis at 12 Months post-Index Procedure; Vascular Access Complications; Heart Block; Gastric Motility / Pyloric Spasm Disorders, Cardiac Tamponade / Perforation; Pericarditis; Severe Hemolysis with Subsequent Renal Injury or Significant Anemia / Within 12 Months onset date: Pulmonary Vein Stenosis; Atrio-Esophageal Fistula)	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Catheter Ablation; Pulsed Field Ablation; FARAPULSE; Workflow Assessment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PF117

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