The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— ERASE-AF  

Official title:

The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732626
• Other study ID #: ERASE V1.3
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2022
• Source: Mödling Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• radiofrequency ablation

Locations

Country	Name	City	State
Austria	Elisabethinen Hospital	Linz	Upper Austria
Austria	Moedling Hospital	Mödling	Lower Austria
Austria	Landesklinikum Wiener Neustadt	Vienna
Germany	Heart Center Dresden	Dresden	Sachsen
Germany	Sana Kliniken Lübeck	Lübeck
Poland	Medical University of Lublin	Lublin

Sponsors (5)

Lead Sponsor	Collaborator
Mödling Hospital	Elisabethinen Hospital, Medical University of Lublin, Medical University of Vienna, Technische Universität Dresden

Countries where clinical trial is conducted

Austria,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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