NCT05293639

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.

Detailed description

This is a prospective, non-randomized, multi-center, clinical evaluation of the Biosense Webster IRE Ablation system to demonstrate safety and long-term effectiveness for the treatment of drug refractory symptomatic PAF. The BWI IRE Ablation System consists of the VARIPULSE™ Catheter and TRUPULSE™ Generator. In conjunction with CARTO™ 3 system, it is indicated for PVI of patients with drug refractory paroxysmal atrial fibrillation.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulse Field Ablation	PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

Timeline

• Start date: 2022-04-18
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2022-03-24
• Last updated: 2025-05-25
• Results posted: 2025-04-04

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated device study