Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation
Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 atrial-fibrillation
Started Aug 2004
Shorter than P25 for phase_4 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMarch 18, 2008
March 1, 2008
September 12, 2005
March 14, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
Study Arms (2)
1
EXPERIMENTALtrigger-guided ablation of paroxysmal atrial fibrillation
2
EXPERIMENTALtrigger-+substrate guided ablation of paroxysmal atrial fibrillation
Interventions
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
Eligibility Criteria
You may qualify if:
- Age \> 18 and \<80 years
- Symptomatic paroxysmal atrial fibrillation
- Drug-refractory
- Anticoagulation
You may not qualify if:
- Hyperthyreosis
- Moderate-to-severe mitral valve valvulopathy
- LV-ejection fraction \<35%
- Prior ablation, PCI or heart surgery \<3 months
- Left atrial thrombus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deutsches Herzzentrum Muenchen
Munich, 80636, Germany
Related Publications (2)
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.
PMID: 15927974BACKGROUNDNademanee 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.
PMID: 15172410BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claus Schmitt, MD
Deutsches Herzzentrum Muenchen
- PRINCIPAL INVESTIGATOR
Isabel Deisenhofer, MD
Deutsches Herzzentrum Muenchen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
August 1, 2004
Study Completion
June 1, 2006
Last Updated
March 18, 2008
Record last verified: 2008-03