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Line Versus Spot Ablation in Persistent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
linear anatomically oriented ablations
focal electrophysiological oriented ablations
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

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

Sites / Locations

  • Deutsches Herzzentrum MuenchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

linear lesions to ablate persistent atrial fibrillation

focal electrophysiologically guided ablations to treat persistent atrial fibrillation

Outcomes

Primary Outcome Measures

Sinus rhythm in follow-up

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
May 28, 2009
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00196157
Brief Title
Line Versus Spot Ablation in Persistent Atrial Fibrillation
Official Title
Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
linear lesions to ablate persistent atrial fibrillation
Arm Title
2
Arm Type
Experimental
Arm Description
focal electrophysiologically guided ablations to treat persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
linear anatomically oriented ablations
Intervention Description
linear lesions to ablate persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
focal electrophysiological oriented ablations
Intervention Description
focal electrophysiologically guided ablations to treat persistent atrial fibrillation
Primary Outcome Measure Information:
Title
Sinus rhythm in follow-up
Time Frame
Sinus rhythm in follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Estner, MD
Phone
0049 89 1218 2020
Email
estner@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Schmitt, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heidi Estner, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Estner, MD
Phone
0049 89 1218 2020
Email
estner@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Heidi Estner, MD

12. IPD Sharing Statement

Learn more about this trial

Line Versus Spot Ablation in Persistent Atrial Fibrillation

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