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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: atrioventricular node ablation

• Registration Number: NCT05211453
• Lead Sponsor: East Sussex Hospitals NHS Trust

Brief Summary

This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation

Detailed Description

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

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-11-09
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-26
• Last Update Submitted: 2022-01-26
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right sided atrioventricular node ablation	atrioventricular node ablation	Right sided atrioventricular node ablation
Left sided atrioventricular node ablation	atrioventricular node ablation	Left sided atrioventricular node ablation

Primary Outcome Measures

Name	Time	Method
Comparison of total ablation time required to induce complete atrioventricular node block	intraoperative	Time in seconds

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eastbourne District General Hospital; 🇬🇧 Eastbourne, East Sussex, United Kingdom