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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05211453
Enrollment
100
Registered
2022-01-27
Start date
2020-11-01
Completion date
2022-11-01
Last updated
2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, atrioventricular node

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

Interventions

atrioventricular node ablation

Sponsors

East Sussex Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of total ablation time required to induce complete atrioventricular node blockintraoperativeTime in seconds

Secondary

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

Countries

United Kingdom

Contacts

Primary ContactRick Veasey
rick.veasey@nhs.net03001315457

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026