Study Results
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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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-11-07
2030-08-18
Brief Summary
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A treatment for AF involves catheter ablation, a minimally invasive procedure where problematic areas of the heart are targeted using controlled energy. This is done by passing wires called catheters, through blood vessels at the top of the leg all the way to the heart. However, this isn't effective for everyone and approximately half of patients experience a return of AF despite treatment.
In this researcher-led study at St Bartholomew's Hospital , the investigators will use a method called electroanatomical mapping to make a 3D picture of the left atrium, the heart's upper left chamber. To make this picture more detailed, information will be collected - such as how strong electrical signals are (voltage), how fast and in which direction they travel through the heart to describe abnormal areas and areas of scar within the heart. Information will also be gathered about the routes electricity takes and the nerve activity in the heart muscle. These detailed maps will help to understand why AF can continue indefinitely in some people, why ablation works for some people and not others, and improve how ablations are done to make them more effective.
All participants will undergo catheter ablation with these mapping methods integrated into the procedure. If AF recurs, patients will be invited for a second ablation targeting specific abnormal areas depending on the amount of scar found. This will be standardised across patients.
Patients will be followed for 12 months, with structured visits at 3, 6, 9 and 12 months and 48-hour ECG recorders at 6 and 12 months. By tracking how the heart's structure and electrical behaviour evolve, the aim is to to see if map-guided ablation reduces the need for further procedures, lowers healthcare costs and improves quality of life.
Ultimately, this study will provide clear, reproducible insights into AF mechanisms and yield practical guidance so clinicians can predict who will benefit from standard ablation treatment and who may require extra, map-guided treatment.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Patients already undergoing a first ablation for persistent atrial fibrillation will undergo extensive structural, electrical and autonomic modelling during their index ablation procedure. They will then be followed up for 1 year.
Those whose AF recurs will be invited for a repeat procedure in which all patients will undergo reisolation of the pulmonary veins and ganglionic plexi. Those whose atria is comprised of low voltage zones more than 30 will additionally undergo susbtrate modification of rate dependent conduction velocity slowing sites. All these patients will then undergo further follow up for 12 months will be compared to propensity matched controls.
OTHER
NONE
Study Groups
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Minimal Low Voltage Zones Group
These are patients who've had recurrence of AF after their first ablation and less than 30% of their atria is comprised of low voltage zones. They will undergo autonomic ganglionic plexi site ablation combined with pulmonary vein re-isolation.
Pulmonary vein reisolation
The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated.
Ganglionic plexi ablation
Sites where ganglionix plexi have been found will be ablated.
Significant Low Voltage Zones Group
These are patients who've had recurrence of AF after their first ablation and greater than 30% of their atria is comprised of low voltage zones. They will undergo targeted ablation of conduction slowing sites in addition to ganlionic plexi site ablation and pulmonary vein reisolation.
Pulmonary vein reisolation
The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated.
Ganglionic plexi ablation
Sites where ganglionix plexi have been found will be ablated.
Substrate ablation
Areas of rate dependent conduction velocity slowing will be targeted using cathether ablation
Interventions
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Pulmonary vein reisolation
The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated.
Ganglionic plexi ablation
Sites where ganglionix plexi have been found will be ablated.
Substrate ablation
Areas of rate dependent conduction velocity slowing will be targeted using cathether ablation
Eligibility Criteria
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Inclusion Criteria
* Age: 18 years or older
* Clinical diagnosis: Persistent atrial fibrillation
* Treatment status: Scheduled to undergo first-time catheter ablation for persistent AF
Exclusion Criteria
* Under 18 years of age
* Previous left atrial ablation for AF or other atrial arrhythmias
* Any clinical contraindications to undergoing AF catheter ablation
18 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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Locations
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St Bartholomew's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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407
Identifier Type: -
Identifier Source: org_study_id
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