NCT06784466

Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Arga Medtech SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

Detailed description

A prospective, multi-center, non-randomized, unblinded pre-market study designed to provide clinical data to support regulatory approval of the Argá Medtech CSE Ablation System for the ablation of atrial fibrillation and adjunctive use for additional atrial ablation. Patients with a history of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PersAF) will, at a minimum, undergo ablative intervention of the pulmonary veins.

Conditions

• Atrial Fibrillation (AF)
• Persistant Atrial Fibrillation
• Paroxysmal AF

Interventions

Type	Name	Description
DEVICE	Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System	Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-01-20
• Last updated: 2026-04-08

Locations

27 sites across 6 countries: United States, Belgium, Croatia, Czechia, Lithuania, Netherlands

Regulatory

• FDA-regulated device study