Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF (ATTAC CFAE)

April 10, 2017 updated by: Deutsches Herzzentrum Muenchen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Karlsruhe, Germany, 76133
        • Klinikum Karlsruhe
      • München, Germany, 80636
        • Deutsches Herzzentrum München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ablation
Ablation of atrial tachycardia
Procedure: Ablation
Ablation of atrial tachycardia
ACTIVE_COMPARATOR: Cardioversion
Cardioversion of atrial tachycardia
Procedure: Cardioversion
Cardioversion of atrial tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Freedom from atrial tachyarrhythmia
Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.

Secondary Outcome Measures

Outcome Measure
Measure Description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

October 26, 2010

First Posted (ESTIMATE)

October 27, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-001

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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