Atrial FibrillationNCT05211453
A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction
A study testing atrioventricular node ablation in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- atrioventricular node ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Referred for atrioventricular node ablation for any such indication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Eastbourne District General Hospital
Eastbourne, East Sussex
Rick Veasey, 03001315457, rick.veasey@nhs.net
About this study
This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation
Read the 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
- Conditions
- Atrial Fibrillation
- Being tested
- atrioventricular node ablation
- Keywords
- atrial fibrillation, atrioventricular node
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atrioventricular node ablationProcedure or surgery
atrioventricular node ablation
| Study group | Role | What they receive |
|---|---|---|
| Right sided atrioventricular node ablation | Active comparator | Right sided atrioventricular node ablation Receives: Procedure: atrioventricular node ablation |
| Left sided atrioventricular node ablation | Active comparator | Left sided atrioventricular node ablation Receives: Procedure: atrioventricular node ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of total ablation time required to induce complete atrioventricular node block
Time in seconds
Measured: intraoperative
Secondary outcomes (7)
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
Measured: intraoperative
Comparison of total procedure time between the two groups
Comparison of total procedure time between the two groups
Measured: intraoperative
Comparison of radiation exposure between the two groups
Comparison of radiation exposure between the two groups
Measured: intraoperative
Comparison of rate of the escape rhythm after ablation in beats/min
Comparison of rate of the escape rhythm after ablation in beats/min
Measured: intraoperative
Comparison of number of patients requiring crossover to each side
Comparison of number of patients requiring crossover to each side
Measured: intraoperative
Comparison of adverse events / complications between each group
Comparison of adverse events / complications between each group
Measured: intraoperative
Comparison of patient comfort of procedure
Comparison of patient comfort of procedure using visual analogue scale ( 0-100)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Nov 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rick Veasey, East Sussex Healthcare NHS Trust
- Investigators
- Rick Veasey, Principal investigator, East Sussex Healthcare NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211453
- Sponsor's protocol ID
- S001
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction
- ClinicalTrials.gov ID
- NCT05211453
- Acronym / sponsor ID
- S001
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrioventricular node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right sided atrioventricular node ablation | Active comparator | Procedure: atrioventricular node ablationRight sided atrioventricular node ablation |
| Left sided atrioventricular node ablation | Active comparator | Procedure: atrioventricular node ablationLeft sided atrioventricular node ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years
- Referred for atrioventricular node ablation for any such indication
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atrioventricular node ablationatrioventricular node ablation | Procedure or surgery | Left sided atrioventricular node ablation, Right sided atrioventricular node ablation |
Primary outcome
Comparison of total ablation time required to induce complete atrioventricular node block
Time frame: intraoperative
Time in seconds
7 secondary outcomes
Comparison of number of RF applications required to induce complete atrioventricular node block
Time frame: intraoperative
Comparison of total procedure time between the two groups
Time frame: intraoperative
Comparison of radiation exposure between the two groups
Time frame: intraoperative
Comparison of rate of the escape rhythm after ablation in beats/min
Time frame: intraoperative
Comparison of number of patients requiring crossover to each side
Time frame: intraoperative
Comparison of adverse events / complications between each group
Time frame: intraoperative
Comparison of patient comfort of procedure
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Veasey principal investigator
East Sussex Healthcare NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atrioventricular node ablation in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rick Veasey (03001315457, rick.veasey@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of total ablation time required to induce complete atrioventricular node block (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.