NCT07281521

Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation

Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CardioFocus · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).

Detailed description

This is a prospective, single-arm, multi-center, clinical study. The study will be conducted at up to 4 centers in Europe. Up to 200 participants will be enrolled and treated. Participants enrolled in Phase A and Phase B will be exited from the study upon completion of the remapping procedure hospital discharge. Participants enrolled in Phase C will be followed through 12 months. All eligible patients who provide written informed consent will be treated with the study device.

Conditions

• Persistant Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	pulsed field ablation	pulsed field ablation with a large-area focal catheter

Timeline

• Start date: 2023-02-27
• Primary completion: 2026-08-01
• Completion: 2027-06-01
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

3 sites across 2 countries: Croatia, Czechia

Regulatory

• FDA-regulated device study