A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction

Study Overview
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Brief Summary
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This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation

Detailed Description
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Right-sided atrioventricular node ablation has been the initial conventional approach however up to 18.5% of patients require switching to a left sided approach or have a challenging procedure. Previous studies have found that left sided ablation is more efficacious than right-sided ablation requiring less than 5 applications of radiofrequency energy to induce atrioventricular block. This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation

Official Title
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A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: atrioventricular node ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years Referred for atrioventricular node ablation for any such indication Exclusion Criteria: Stroke or transient ischaemic attack (TIA) within 6 months Myocardial infarction within 6 months Medical conditions limiting expected survival to <1 year Moderate to severe aortic stenosis History of aortic or mitral valve replacement Pregnancy or breast feeding women

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: Right sided atrioventricular node ablation<br>Right sided atrioventricular node ablation | Procedure: atrioventricular node ablation<br>* atrioventricular node ablation<br>|
| Active Comparator: Left sided atrioventricular node ablation<br>Left sided atrioventricular node ablation | Procedure: atrioventricular node ablation<br>* atrioventricular node ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of total ablation time required to induce complete atrioventricular node block | Time in seconds | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of number of RF applications required to induce complete atrioventricular node block | Comparison of number of RF applications required to induce complete atrioventricular node block | intraoperative | 
| Comparison of total procedure time between the two groups | Comparison of total procedure time between the two groups | intraoperative | 
| Comparison of radiation exposure between the two groups | Comparison of radiation exposure between the two groups | intraoperative | 
| Comparison of rate of the escape rhythm after ablation in beats/min | Comparison of rate of the escape rhythm after ablation in beats/min | intraoperative | 
| Comparison of number of patients requiring crossover to each side | Comparison of number of patients requiring crossover to each side | intraoperative | 
| Comparison of adverse events / complications between each group | Comparison of adverse events / complications between each group | intraoperative | 
| Comparison of patient comfort of procedure | Comparison of patient comfort of procedure using visual analogue scale ( 0-100) | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, atrioventricular node