The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation (ERASE-AF)

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.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: radiofrequency ablation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Landesklinikum Wiener Neustadt
  • Lower Austria
    • Mödling, Lower Austria, Austria, 2340
      • Moedling Hospital
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Elisabethinen Hospital
• Germany
  • Lübeck, Germany
    • Sana Kliniken Lubeck
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Heart Center Dresden
• Poland
  • Lublin, Poland
    • Medical University of Lublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pulmonary vein isolation alone; patients randomized to this group receive stand alone pulmonary vein isolation regardless to their left atrial voltage map	Procedure: radiofrequency ablation
Experimental: 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	Procedure: radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoint	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	12 months
Secondary Safety Endpoint	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	90 days

Collaborators and Investigators

• Sponsor: Mödling Hospital
• Collaborators: Medical University of Vienna; Technische Universität Dresden; Medical University of Lublin; Elisabethinen Hospital
• Investigators: Principal Investigator: Christopher Piorkowski, MD, Heart Center Dresden

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ERASE V1.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided