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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
atrioventricular node ablation
Sponsored by
East Sussex Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, atrioventricular node

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastbourne District General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Right sided atrioventricular node ablation

Left sided atrioventricular node ablation

Arm Description

Right sided atrioventricular node ablation

Left sided atrioventricular node ablation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Comparison of total procedure time between the two groups
Comparison of total procedure time between the two groups
Comparison of radiation exposure between the two groups
Comparison of radiation exposure between the two groups
Comparison of rate of the escape rhythm after ablation in beats/min
Comparison of rate of the escape rhythm after ablation in beats/min
Comparison of number of patients requiring crossover to each side
Comparison of number of patients requiring crossover to each side
Comparison of adverse events / complications between each group
Comparison of adverse events / complications between each group
Comparison of patient comfort of procedure
Comparison of patient comfort of procedure using visual analogue scale ( 0-100)

Full Information

First Posted
November 9, 2021
Last Updated
January 26, 2022
Sponsor
East Sussex Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05211453
Brief Title
A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction
Official Title
A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Sussex Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, atrioventricular node

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Right sided atrioventricular node ablation
Arm Type
Active Comparator
Arm Description
Right sided atrioventricular node ablation
Arm Title
Left sided atrioventricular node ablation
Arm Type
Active Comparator
Arm Description
Left sided atrioventricular node ablation
Intervention Type
Procedure
Intervention Name(s)
atrioventricular node ablation
Intervention Description
atrioventricular node ablation
Primary Outcome Measure Information:
Title
Comparison of total ablation time required to induce complete atrioventricular node block
Description
Time in seconds
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Comparison of number of RF applications required to induce complete atrioventricular node block
Description
Comparison of number of RF applications required to induce complete atrioventricular node block
Time Frame
intraoperative
Title
Comparison of total procedure time between the two groups
Description
Comparison of total procedure time between the two groups
Time Frame
intraoperative
Title
Comparison of radiation exposure between the two groups
Description
Comparison of radiation exposure between the two groups
Time Frame
intraoperative
Title
Comparison of rate of the escape rhythm after ablation in beats/min
Description
Comparison of rate of the escape rhythm after ablation in beats/min
Time Frame
intraoperative
Title
Comparison of number of patients requiring crossover to each side
Description
Comparison of number of patients requiring crossover to each side
Time Frame
intraoperative
Title
Comparison of adverse events / complications between each group
Description
Comparison of adverse events / complications between each group
Time Frame
intraoperative
Title
Comparison of patient comfort of procedure
Description
Comparison of patient comfort of procedure using visual analogue scale ( 0-100)
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rick Veasey
Phone
03001315457
Email
rick.veasey@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Veasey
Organizational Affiliation
East Sussex Healthcare NHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
East Sussex
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rick Veasey
Phone
03001315457
Email
rick.veasey@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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