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

January 26, 2022 updated by: Rick Veasey, East Sussex Hospitals NHS Trust
This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • East Sussex
      • Eastbourne, East Sussex, United Kingdom
        • Recruiting
        • Eastbourne District General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Right sided atrioventricular node ablation
Procedure: atrioventricular node ablation
atrioventricular node ablation
ACTIVE_COMPARATOR: Left sided atrioventricular node ablation
Procedure: atrioventricular node ablation
atrioventricular node ablation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Sussex Hospitals NHS Trust

Investigators

  • Principal Investigator: Rick Veasey, East Sussex Healthcare NHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

January 26, 2022

First Posted (ACTUAL)

January 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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