Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: trigger-guided catheter-ablation
* Procedure: trigger+substrate-guided catheter ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>trigger-guided ablation of paroxysmal atrial fibrillation | Procedure: trigger-guided catheter-ablation<br>* trigger-guided ablation of paroxysmal atrial fibrillation<br>|
| Experimental: 2<br>trigger-+substrate guided ablation of paroxysmal atrial fibrillation | Procedure: trigger+substrate-guided catheter ablation<br>* trigger-+substrate guided ablation of paroxysmal atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |