Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF

Not Applicable

Completed

• Conditions: Ablation; Atrial Flutter; Atrial Fibrillation
• Interventions: Procedure: Cardioversion; Procedure: Ablation

• Registration Number: NCT01229033
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum.

When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear.

In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2013-01
• Study Completion: 2014-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Patients (>=18 und < 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR).
• At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
• Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR > 2..
• Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
• Atrial tachycardia occurring during ablation of CFAE (defined as CL > 200 msec und stable activation sequence).

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardioversion	Cardioversion	Cardioversion of atrial tachycardia
Ablation	Ablation	Ablation of atrial tachycardia

Primary Outcome Measures

Name	Time	Method
Freedom from atrial tachyarrhythmia		Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.

Secondary Outcome Measures

Name	Time	Method
Procedural and safety data		1. Duration of left atrial procedure, time of ablation, time of radiation and radiation dose from randomization until the end of the procedure.; 2. In case of recurrence, characteristic of predominant tachyarrhythmia (AF or AT).; 3. Safety parameters (pericardial tamponade, thrombembolic complications).; 4. Number of re-ablations.

Trial Locations

Locations (2)

Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany