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

NCT ID: NCT05211453

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-01

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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Right sided atrioventricular node ablation

Right sided atrioventricular node ablation

Group Type ACTIVE_COMPARATOR

atrioventricular node ablation

Intervention Type PROCEDURE

atrioventricular node ablation

Left sided atrioventricular node ablation

Left sided atrioventricular node ablation

Group Type ACTIVE_COMPARATOR

atrioventricular node ablation

Intervention Type PROCEDURE

atrioventricular node ablation

Interventions

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atrioventricular node ablation

atrioventricular node ablation

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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East Sussex Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Rick Veasey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rick Veasey

Role: PRINCIPAL_INVESTIGATOR

East Sussex Healthcare NHS

Locations

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Eastbourne District General Hospital

Eastbourne, East Sussex, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rick Veasey

Role: CONTACT

03001315457

Facility Contacts

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Rick Veasey

Role: primary

03001315457

Other Identifiers

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S001

Identifier Type: -

Identifier Source: org_study_id

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