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

NCT01229033 | Completed

• 1 other identifier: GER-EP-001
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

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).

Conditions

Atrial Fibrillation; Ablation; Atrial Flutter

Keywords

Atrial fibrillation; ablation; atrial flutter

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial tachyarrhythmia

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

Secondary Outcomes (1)

• Procedural and safety data

Study Arms (2)

Ablation

ACTIVE COMPARATOR

Ablation of atrial tachycardia

Procedure: Ablation

Cardioversion

ACTIVE COMPARATOR

Cardioversion of atrial tachycardia

Procedure: Cardioversion

Interventions

Ablation PROCEDURE

Ablation of atrial tachycardia

Ablation

Cardioversion PROCEDURE

Cardioversion of atrial tachycardia

Cardioversion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt: collaborator

Study Sites (2)

Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Isabel Deisenhofer, MD

  Deutsches Herzzentrum München

  STUDY CHAIR

• Clemens Jilek, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

DE (2)