The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation

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

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-12-31

Brief Summary

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This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation lines in addition to pulmonary vein isolation may improve the outcome in patients with persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.

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Detailed Description

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This is a prospective, randomized multi center study comparing two catheter ablation strategies (pulmonary vein isolation (PVI) versus PVI plus low voltage areas (LVA) guided for ablation in patients with symptomatic persistent and long standing persistent atrial fibrillation (AF) who were unresponsive to at least one Class I or III antiarrhythmic agents, or it is the patient´s decision to receive ablation as first line therapy. Patients with documented persistent AF who are eligible for participation in the study, and gave a written informed consent, will be randomized between two groups prior to the procedure: PVI and PVI+LVAs guided radiofrequency catheter ablation.

All the patients will receive a high density voltage map in sinus rhythm (SR). All the patients will receive circumferential PVI. If LVAs are present, Patients randomized to the PVI+LVA group will get additional linear ablation lines to exclude these areas from normal voltage atrial myocardium. The patients will be followed for 12 months.

Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pulmonary vein isolation alone

patients randomized to this group receive stand alone pulmonary vein isolation regardless to their left atrial voltage map

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

pulmonary vein isolation + low voltage area guided ablation

patients randomized to this group receive pulmonary vein isolation + low voltage area guided linear substrate modification in the case if there are any

Group Type EXPERIMENTAL

radiofrequency ablation

Intervention Type PROCEDURE

Interventions

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radiofrequency ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic patients with persistent AF documented by 12 lead ECGs (Persistent AF is defined as an AF episode which lasts longer than 7 days, Persistent AF which lasted longer than 12 months will be defined as long standing persistent AF.)
* Age 18 - 80 years, both genders
* Patient is willing to participate in the study (signed written informed consent)
* Patient is willing and available to perform all follow ups.

Exclusion Criteria

* Atrial fibrillation due to reversible causes
* Any contraindication for AF ablation
* Contraindications to anticoagulation
* CVA/TIA in the past 6 months
* Previous left atrial catheter ablation

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No