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Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

NCT ID: NCT06124690

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-09-01

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.

Conditions

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Persistent Atrial Fibrillation Catheter Ablation Low Voltage Areas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pulmonary vein isolation (no low voltage)

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

Group Type ACTIVE_COMPARATOR

Catheter ablation

Intervention Type DEVICE

Pulmonary vein isolation and ablation of low voltage areas.

Pulmonary vein isolation only (evidence of low voltage areas)

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

Group Type ACTIVE_COMPARATOR

Catheter ablation

Intervention Type DEVICE

Pulmonary vein isolation and ablation of low voltage areas.

Pulmonary vein isolation plus ablation of low voltage areas

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

Group Type ACTIVE_COMPARATOR

Catheter ablation

Intervention Type DEVICE

Pulmonary vein isolation and ablation of low voltage areas.

Interventions

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Catheter ablation

Pulmonary vein isolation and ablation of low voltage areas.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Minors
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Bosch Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cathrin Theis

Principal Invetsigator, Head of Electrophysiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Robert Bosch Health Coampus

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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Stuttgart, EP-004

Identifier Type: -

Identifier Source: org_study_id