NCT04056390

Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Cardioangiologisches Centrum Bethanien · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation. The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation. After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification. After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) \< 0.5mV. Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance). The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting \> 30 seconds between day 91 and 365 after the index procedure.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy	Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-02-15
• Completion: 2025-02-15
• First posted: 2019-08-14
• Last updated: 2023-11-14

Locations

7 sites across 1 country: Germany