NCT06808217

A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 550 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.

Conditions

• Atrial Fibrillation
• Pulsed Field Ablation
• FARAPULSE

Interventions

Type	Name	Description
DEVICE	FARAPULSE Pulsed Field Ablation System	Subjects who have provided written informed consent are considered enrolled. Subjects who have received ablation treatment with the FARAPULSE™ System are assigned to the 'TREATMENT' group.

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-02-05
• Last updated: 2026-04-14

Locations

22 sites across 10 countries: Austria, France, Germany, Greece, Ireland, Italy, Monaco, Netherlands, Spain, Switzerland