NCT05072964

The FARAPULSE FARA-Freedom Trial

The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Detailed description

The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF). The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure. The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 \~ 36 months of follow-up post-pulsed field ablation procedure. The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34\~36 months of follow-up post-pulsed field ablation procedure.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	FARAPULSE Pulsed Field Ablation System	A pulmonary vein isolation will be performed using catheter ablation

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-10-12
• Completion: 2023-10-19
• First posted: 2021-10-11
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

13 sites across 6 countries: Belgium, Czechia, Denmark, Germany, Netherlands, Switzerland

Regulatory

• FDA-regulated device study