Line Versus Spot Ablation in Persistent Atrial Fibrillation - Full Text View

Sponsored by:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00196157

Purpose

In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: linear anatomically oriented ablations Procedure: focal electrophysiological oriented ablations	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Sinus rhythm in follow-up [ Time Frame: Sinus rhythm in follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	116
Study Start Date:	August 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental linear lesions to ablate persistent atrial fibrillation	Procedure: linear anatomically oriented ablations linear lesions to ablate persistent atrial fibrillation
2: Experimental focal electrophysiologically guided ablations to treat persistent atrial fibrillation	Procedure: focal electrophysiological oriented ablations focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Detailed Description:

This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation:

a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.

The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age between 18 and 80 years
symptomatic persistent (> 7 days lasting) atrial fibrillation
at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
oral anticoagulation (> 4 weeks prior to ablation)

Exclusion Criteria:

moderate to severe valvular heart disease
congenital heart disease
LV-EF < 35%
reversible cause for atrial fibrillation (e.g., hyperthyreosis)
prior left atrial ablation or Maze operation
left atrial thrombus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196157

Contacts

Contact: Heidi Estner, MD

0049 89 1218 2020

estner@dhm.mhn.de

Locations

Germany
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80636
Contact: Heidi Estner, MD 0049 89 1218 2020 estner@dhm.mhn.de
Principal Investigator: Heidi Estner, MD

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Claus Schmitt, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Heidi Estner, MD	Deutsches Herzzentrum Muenchen

More Information

No publications provided

Responsible Party:	Deutsches Herzzentrum Munich ( Prof. A. Schömig )
Study ID Numbers:	GE IDE No. C00604
Study First Received:	September 12, 2005
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00196157 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 03, 2009