Adenosine vs AF Termination for Paroxysmal AF Ablation

Study Overview
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Brief Summary
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This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.

Detailed Description
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Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome. A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.

Official Title
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Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Adenosine test
* Procedure: Termination of AF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with paroxysmal AF de-novo AF ablation age > 18 years Exclusion Criteria: persistent AF previous cardioversion

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Group A<br>Adenosine testing after PVI and elimination of dormant conduction | Procedure: Adenosine test<br>* Testing dormant conduction after PVI<br>|
| Active Comparator: Group B - Termination of AF<br>Termination of atrial fibrillation by catheter ablation | Procedure: Termination of AF<br>* Testing AF iducibility and ermination of<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia-free survival | arrhythmia-free outcome during 1 year after the procedure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence if PV conduction after ablation in PVs with abolished dormant conduction | PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paroxysmal atrial fibrillation, pulmonary vein isolation, adenosine, AF terminatin