Trials / Active Not Recruiting
Active Not RecruitingNCT06656884
FARAPULSE Workflow Assessment Registry
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 524 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2025-05-06
- Primary completion
- 2027-02-15
- Completion
- 2027-02-15
- First posted
- 2024-10-24
- Last updated
- 2026-04-14
Locations
28 sites across 10 countries: Austria, Belgium, France, Germany, Greece, Italy, Saudi Arabia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT06656884. Inclusion in this directory is not an endorsement.