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Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
trigger-guided catheter-ablation
trigger+substrate-guided catheter ablation
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 > 18 and <80 years Symptomatic paroxysmal atrial fibrillation Drug-refractory Anticoagulation Exclusion Criteria: Hyperthyreosis Moderate-to-severe mitral valve valvulopathy LV-ejection fraction <35% Prior ablation, PCI or heart surgery <3 months Left atrial thrombus

Sites / Locations

  • Deutsches Herzzentrum Muenchen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

trigger-guided ablation of paroxysmal atrial fibrillation

trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Outcomes

Primary Outcome Measures

Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
March 14, 2008
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00196183
Brief Title
Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation
Official Title
Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.
Detailed Description
Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (AF). However, discussion about the best ablation strategy is still ongoing. In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV) eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described. The first describer of this technique reports curing rates of 92%. We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment.

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
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
trigger-guided ablation of paroxysmal atrial fibrillation
Arm Title
2
Arm Type
Experimental
Arm Description
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
trigger-guided catheter-ablation
Intervention Description
trigger-guided ablation of paroxysmal atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
trigger+substrate-guided catheter ablation
Intervention Description
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
Primary Outcome Measure Information:
Title
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
Time Frame
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation

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 > 18 and <80 years Symptomatic paroxysmal atrial fibrillation Drug-refractory Anticoagulation Exclusion Criteria: Hyperthyreosis Moderate-to-severe mitral valve valvulopathy LV-ejection fraction <35% Prior ablation, PCI or heart surgery <3 months Left atrial thrombus
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
Isabel Deisenhofer, 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

12. IPD Sharing Statement

Citations:
PubMed Identifier
15927974
Citation
Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.
Results Reference
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PubMed Identifier
15172410
Citation
Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
Results Reference
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Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

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