NCT05572047

Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Arga Medtech SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.

Detailed description

A prospective, single-arm, multi-center, multi-national, non-randomized study designed to provide clinical data to support the use of the Arga Medtech System in the ablation of atrial fibrillation. Patients with paroxysmal AF will be treated using the Arga Medtech System to achieve pulmonary vein isolation (PVI) (and cavo-tricuspid isthmus (CTI) ablation as appropriate if history of CTI flutter or inducible flutter during procedure) Patients with persistent AF will be treated using the Arga Medtech System to achieve PVI and posterior wall (PW) ablation (CTI ablation as above). Patients will be remapped at 90 days post the index procedure to confirm absence of PV reconnection and durability of any additional lesion sets performed. Re-ablation is permitted during the remapping procedure if indicated. Re-ablation resets the 90-day blanking period. Additional follow-ups will be conducted at 7 days, 30 days, 180 days and 360 days post the index or re-ablation procedure.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System	Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF

Timeline

• Start date: 2022-10-11
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2022-10-07
• Last updated: 2025-12-05

Locations

3 sites across 2 countries: Croatia, Georgia

Regulatory

• FDA-regulated device study