Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

Not Applicable

Active, not recruiting

• Conditions: Low Voltage Areas; Persistent Atrial Fibrillation; Catheter Ablation
• Interventions: Device: Catheter ablation

• Registration Number: NCT06124690
• Lead Sponsor: Robert Bosch Medical Center

Brief Summary

An effective therapy of persistent atrial fibrillation beyond pulmonary vein isolation remains unsatisfactory. Targeting endocardial low-voltage areas represents an approach of substrate modification.

This prospective, randomized study investigated the efficacy of ablation of low-voltage areas versus PVI and additional linear ablations in patients with persistent atrial fibrillation in terms of single-procedure arrhythmia-free outcome and safety.

Detailed Description

Pulmonary vein isolation has become the cornerstone of the interventional treatment of paroxysmal atrial fibrillation. For the treatment of persistent atrial fibrillation the data remains unclear. All different approaches remain unsatisfactory for the treatment of persistent atrial fibrillation, including single pulmonary vein isolation, targeting endocardial areas of low-voltage, identifying areas with complex fractionated atrial electrograms (CFAE), ablating linear lines such as an anterior line, a roof-line or mitral isthmus line. Recurrence rates are still higher as compared to paroxysmal atrial fibrillation ablation. Several studies showed a good correlation between the volume of low-voltage areas (LVA) and the burden of atrial fibrillation. Earlier studies that investigated ablation therapy using a substrate-guided ablation as compared to circumferential pulmonary vein isolation (CPVI) alone, mostly showed no significant difference in recurrence rates between both approaches. In contrast, some other studies showed better outcomes when targeting low-voltage areas. However, there was significant heterogeneity in patient selection, mapping and ablation strategies and therefore, comparisons are hard to make.

The patients are randomized into three different treatment arms (Group 1: PVI alone if no low voltage areas are detected, Group 2: PVI alone if low voltage areas are detected, Group 3: PVI plus ablation of low voltage areas.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Persistent atrial fibrillation according to the current guidelines
• Age > 18 years
• Patient information

Exclusion Criteria

• Minors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary vein isolation (no low voltage)	Catheter ablation	Patients without the presence of low voltage areas receive pulmonary vein isolation only.
Pulmonary vein isolation only (evidence of low voltage areas)	Catheter ablation	Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas.
Pulmonary vein isolation plus ablation of low voltage areas	Catheter ablation	Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas.

Primary Outcome Measures

Name	Time	Method
Number of participants with atrial arrhythmia recurrence after 12 months follow-up	12 months	Number of participants with atrial arrhythmia recurrence after 12 months follow-up

Secondary Outcome Measures

Name	Time	Method
Number of procedural complications	12 months	Number of procedural complications.

Trial Locations

Locations (1)

Robert Bosch Health Coampus; 🇩🇪 Stuttgart, Baden-Wuerttemberg, Germany