NCT06762717

FARAPULSE™ Pulsed Field Ablation System

Real World Data Collection in Chinese Population Treated With the FARAPULSE™ Pulsed Field Ablation System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.

Detailed description

The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study. All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years. Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).

Conditions

• Paroxysmal AF

Interventions

Type	Name	Description
DEVICE	FARAPULSE™ Pulsed Field Ablation system	no intervention design in the study

Timeline

• Start date: 2025-10-23
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-01-08
• Last updated: 2026-03-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study