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

Primary Purpose

Atrial Fibrillation, Ablation, Atrial Flutter

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Ablation

Cardioversion

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, ablation, atrial flutter

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Klinikum Karlsruhe
Deutsches Herzzentrum München

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ablation

Cardioversion

Arm Description

Ablation of atrial tachycardia

Cardioversion of atrial tachycardia

Outcomes

Primary Outcome Measures

Freedom from atrial tachyarrhythmia

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01229033

First Posted

October 26, 2010

Last Updated

April 10, 2017

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01229033

Brief Title

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

Acronym

ATTAC CFAE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Ablation, Atrial Flutter

Keywords

Atrial fibrillation, ablation, atrial flutter

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ablation

Arm Type

Active Comparator

Arm Description

Ablation of atrial tachycardia

Arm Title

Cardioversion

Arm Type

Active Comparator

Arm Description

Cardioversion of atrial tachycardia

Intervention Type

Procedure

Intervention Name(s)

Ablation

Intervention Description

Ablation of atrial tachycardia

Intervention Type

Procedure

Intervention Name(s)

Cardioversion

Intervention Description

Cardioversion of atrial tachycardia

Primary Outcome Measure Information:

Title

Freedom from atrial tachyarrhythmia

Description

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

Secondary Outcome Measure Information:

Title

Procedural and safety data

Description

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabel Deisenhofer, MD

Organizational Affiliation

Deutsches Herzzentrum München

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Clemens Jilek, MD

Organizational Affiliation

Deutsches Herzzentrum München

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Karlsruhe

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Deutsches Herzzentrum München

City

München

ZIP/Postal Code

80636

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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