Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Recurrence

• Registration Number: NCT02059369
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with symptomatic persistent AF
• After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia

Exclusion Criteria

• Left atrial thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmia	12 months	Documented freedom from atrial arrhythmia (AF or AT) recurrence

Secondary Outcome Measures

Name	Time	Method
Procedural and safety data	12 months	Duration of procedure, ablation time, fluoroscopy time and complications
Number and result of reablation procedure	12 months	Number of redo procedures, results and type of recurrent arrhythmia

Trial Locations

Locations (1)

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany