Line Versus Spot Ablation in Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00196157
• Other study ID #: GE IDE No. C00604
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: May 28, 2009
• Start date: August 2004
• Est. completion date: November 2008

Study information

• Verified date: May 2009
• Source: Deutsches Herzzentrum Muenchen
• Contact: Heidi Estner, MD
• Phone: 0049 89 1218 2020
• Email: estner[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: November 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• linear anatomically oriented ablations
linear lesions to ablate persistent atrial fibrillation
• focal electrophysiological oriented ablations
focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus rhythm in follow-up		Sinus rhythm in follow-up	No