Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas: a Prospective Randomized Trial

Conditions
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Persistent Atrial Fibrillation, Catheter Ablation, Low Voltage Areas

Intervention / Treatment
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* Device: Catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent atrial fibrillation according to the current guidelines Age > 18 years Patient information Exclusion Criteria: Minors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with persistent atrial fibrillation are included in the study. They are randomized into three diffrenet treatment arms depending on the presence of left atrial fibrosis.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary vein isolation (no low voltage)<br>Patients without the presence of low voltage areas receive pulmonary vein isolation only. | Device: Catheter ablation<br>* Pulmonary vein isolation and ablation of low voltage areas.<br>|
| Active Comparator: Pulmonary vein isolation only (evidence of low voltage areas)<br>Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas. | Device: Catheter ablation<br>* Pulmonary vein isolation and ablation of low voltage areas.<br>|
| Active Comparator: Pulmonary vein isolation plus ablation of low voltage areas<br>Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas. | Device: Catheter ablation<br>* Pulmonary vein isolation and ablation of low voltage areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with atrial arrhythmia recurrence after 12 months follow-up | Number of participants with atrial arrhythmia recurrence after 12 months follow-up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedural complications | Number of procedural complications. | 12 months |