Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

Robert Bosch Medical Center

Status: Active, not recruiting

Conditions: Low Voltage Areas; Persistent Atrial Fibrillation; Catheter Ablation

Treatments: Device: Catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06124690

Stuttgart, EP-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Minors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Pulmonary vein isolation (no low voltage)

Active Comparator group

Description:

Patients without the presence of low voltage areas receive pulmonary vein isolation only.

Treatment:

Device: Catheter ablation

Pulmonary vein isolation only (evidence of low voltage areas)

Active Comparator group

Description:

Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas.

Treatment:

Device: Catheter ablation

Pulmonary vein isolation plus ablation of low voltage areas

Active Comparator group

Description:

Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas.

Treatment:

Device: Catheter ablation