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

Atrial Fibrillation Clinical Trial

— ATTAC CFAE  

Official title:

Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229033
• Other study ID #: GER-EP-001
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: April 10, 2017
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: April 2017
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Ablation
• Atrial Fibrillation
• Atrial Flutter
• Tachycardia

Intervention

Procedure:
• Ablation
Ablation of atrial tachycardia
• Cardioversion
Cardioversion of atrial tachycardia

Locations

Country	Name	City	State
Germany	Klinikum Karlsruhe	Karlsruhe
Germany	Deutsches Herzzentrum München	München

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial tachyarrhythmia	Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.
Secondary	Procedural and safety data	Duration of left atrial procedure, time of ablation, time of radiation and radiation dose from randomization until the end of the procedure.; In case of recurrence, characteristic of predominant tachyarrhythmia (AF or AT).; Safety parameters (pericardial tamponade, thrombembolic complications).; Number of re-ablations.