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NCT Number: NCT02732626

The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation

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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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moedling Hospital, Mödling, Lower Austria, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

Primary outcomes

  1. recurrence of atrial arrhythmia

    Time frame: 12 months

    recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking

Secondary outcomes

  1. Secondary Efficacy Endpoint

    Time frame: 12 months

    recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking, on implanted cardiac monitors exclusively

  2. Secondary Safety Endpoint

    Time frame: 90 days

    occurrence of one or more of the following adverse events within 90 days from ablation: cardiac tamponade/hemopericardium/effusion, pericarditis, stroke/TIA/arterial embolism, pulmonary vein stenosis, atrioesophageal fistula, septicemia, internal bleeding, phrenic nerve palsy, femoral vascular access complication, death

Sponsors and collaborators

Lead sponsor

Mödling Hospital

Other

Collaborators

  • Elisabethinen Hospital
  • Medical University of Lublin
  • Medical University of Vienna
  • Technische Universität Dresden

Registry information

Acronym: ERASE-AF

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2016
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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