NCT05501873

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,173 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	FARAPULSE Pulsed Field Ablation system	Any subject who has signed the informed consent and for whom the FARAPULSE Pulsed Field Ablation system has been inserted into the body, and pulsed field ablation treatment has been received, are assigned to the treatment group.

Timeline

• Start date: 2023-03-24
• Primary completion: 2025-10-21
• Completion: 2027-08-15
• First posted: 2022-08-16
• Last updated: 2026-03-17

Locations

48 sites across 21 countries: Australia, Austria, Belgium, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Malaysia, Monaco, Netherlands, Poland, Portugal, Saudi Arabia, Spain, United Kingdom