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FARAPULSE Workflow Assessment Registry

NCT06656884 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 524

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2027-02-15
Completion
2027-02-15

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656884 on ClinicalTrials.gov