- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732626
The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation (ERASE-AF)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vienna, Austria
- Landesklinikum Wiener Neustadt
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Lower Austria
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Mödling, Lower Austria, Austria, 2340
- Moedling Hospital
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Elisabethinen Hospital
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Lübeck, Germany
- Sana Kliniken Lübeck
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Sachsen
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Dresden, Sachsen, Germany, 01307
- Heart Center Dresden
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Lublin, Poland
- Medical University of Lublin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence of atrial arrhythmia
Time Frame: 12 months
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recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Efficacy Endpoint
Time Frame: 12 months
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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
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12 months
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Secondary Safety Endpoint
Time Frame: 90 days
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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
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90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Piorkowski, MD, Heart Center Dresden
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERASE V1.3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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