NCT05211453

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

November 9, 2021

Last Update Submit

January 26, 2022

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationatrioventricular node

Outcome Measures

Primary Outcomes (1)

  • Comparison of total ablation time required to induce complete atrioventricular node block

    Time in seconds

    intraoperative

Secondary Outcomes (7)

  • Comparison of number of RF applications required to induce complete atrioventricular node block

    intraoperative

  • Comparison of total procedure time between the two groups

    intraoperative

  • Comparison of radiation exposure between the two groups

    intraoperative

  • Comparison of rate of the escape rhythm after ablation in beats/min

    intraoperative

  • Comparison of number of patients requiring crossover to each side

    intraoperative

  • +2 more secondary outcomes

Study Arms (2)

Right sided atrioventricular node ablation

ACTIVE COMPARATOR

Right sided atrioventricular node ablation

Procedure: atrioventricular node ablation

Left sided atrioventricular node ablation

ACTIVE COMPARATOR

Left sided atrioventricular node ablation

Procedure: atrioventricular node ablation

Interventions

atrioventricular node ablationPROCEDURE

atrioventricular node ablation

Left sided atrioventricular node ablationRight sided atrioventricular node ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years
  • Referred for atrioventricular node ablation for any such indication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastbourne District General Hospital

Eastbourne, East Sussex, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rick Veasey

    East Sussex Healthcare NHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Veasey

CONTACT

03001315457rick.veasey@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2021

First Posted

January 27, 2022

Study Start

November 1, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)