Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation
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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.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Procedure: trigger-guided catheter-ablation Procedure: trigger+substrate-guided catheter ablation |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation |
- 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 ]
Enrollment: | 98 |
Study Start Date: | August 2004 |
Study Completion Date: | June 2006 |
Arms | Assigned Interventions |
---|---|
Experimental: 1
trigger-guided ablation of paroxysmal atrial fibrillation
|
Procedure: trigger-guided catheter-ablation
trigger-guided ablation of paroxysmal atrial fibrillation
|
Experimental: 2
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
|
Procedure: trigger+substrate-guided catheter ablation
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
|
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Germany | |
Deutsches Herzzentrum Muenchen | |
Munich, Germany, 80636 |
Study Chair: | Claus Schmitt, MD | Deutsches Herzzentrum Muenchen |
Principal Investigator: | Isabel Deisenhofer, MD | Deutsches Herzzentrum Muenchen |
Publications:
ClinicalTrials.gov Identifier: | NCT00196183 History of Changes |
Other Study ID Numbers: | GE IDE No. C00504 |
Study First Received: | September 12, 2005 |
Last Updated: | March 14, 2008 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on October 16, 2012