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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211453
• Other study ID #: S001
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2022
• Source: East Sussex Hospitals NHS Trust
• Contact: Rick Veasey
• Phone: 03001315457
• Email: rick.veasey[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• atrioventricular node ablation
atrioventricular node ablation

Locations

Country	Name	City	State
United Kingdom	Eastbourne District General Hospital	Eastbourne	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
East Sussex Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of total ablation time required to induce complete atrioventricular node block	Time in seconds	intraoperative
Secondary	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
Secondary	Comparison of total procedure time between the two groups	Comparison of total procedure time between the two groups	intraoperative
Secondary	Comparison of radiation exposure between the two groups	Comparison of radiation exposure between the two groups	intraoperative
Secondary	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
Secondary	Comparison of number of patients requiring crossover to each side	Comparison of number of patients requiring crossover to each side	intraoperative
Secondary	Comparison of adverse events / complications between each group	Comparison of adverse events / complications between each group	intraoperative
Secondary	Comparison of patient comfort of procedure	Comparison of patient comfort of procedure using visual analogue scale ( 0-100)	intraoperative