AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique)

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVI with substrate ablation; Procedure: PVI only

• Registration Number: NCT04773119
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

Recent publications suggest that neither empirical nor individualized substrate modification strategies could improve single-procedure efficacy beyond pulmonary vein (PV) isolation for persistent atrial fibrillation (AF). However, persistent AF represent a broad spectrum of the same disease and if PV isolation may be sufficient for some patient with self-terminated AF or with a small left atrium, a more extended substrate ablation may be required for other patients, for which a second procedure for atrial tachycardia (AT) recurrence is then frequently needed. In addition, a lot of progress has recently been made in the field of ablation techniques using contiguous and optimized ablation radiofrequency (RF) lesions and also for AT mapping with promising results using repetitive but discontinuous Holter monitoring.

This trial aims at

1. To objectively compare atrial tachyarrhythmia (ATA) burden \> 2 months before ablation and after one or two 'CLOSEMAZE'-guided ablation(s) using continuous monitoring and echo data as a guide for the ablation strategy during the first ablation.

2. To assess ATA burden using continuous monitoring up to 3 years after ablation.

3. To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-10
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-02-26
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI with substrate	PVI with substrate ablation	-
Pulmonary vein isolation (PVI) only	PVI only	-

Primary Outcome Measures

Name	Time	Method
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy	CLR implant to 3 year post ablation	ATA burden (= time that a subject experiences AF) will be monitored with continuous loop recording (CLR) from time of CLR implant until 3 years after ablation

Secondary Outcome Measures

Name	Time	Method
Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation	3 years after ablation	ATA burden after first ablation documented through continuous loop recordings
Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation	3 years after ablation	ATA burden after two ablations documented through continuous loop recordings

Trial Locations

Locations (1)

AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Brugge, West-Flanders, Belgium