Substrate Remodelling and Targeted Ablation in AF

NCT ID: NCT07047235

Last Updated: 2025-11-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2030-08-18

Brief Summary

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Atrial fibrillation (AF) is the most common heart rhythm disorder, affecting millions worldwide and causing symptoms such as palpitations, fatigue and breathlessness. It also increases the risk of stroke and heart failure, so effective treatment is essential.

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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF) Atrial Fibrillation Mechanisms Catheter Ablation Low Voltage Areas

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study is a single-centre, prospective mechanistic cohort investigation with a nested interventional controlled study designed to comprehensively evaluate electrophysiological substrate remodelling and its relationship with procedural outcomes in patients undergoing catheter ablation for persistent AF.

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.
Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Pulmonary vein reisolation

Intervention Type PROCEDURE

The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated.

Ganglionic plexi ablation

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Pulmonary vein reisolation

Intervention Type PROCEDURE

The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated.

Ganglionic plexi ablation

Intervention Type PROCEDURE

Sites where ganglionix plexi have been found will be ablated.

Substrate ablation

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Ganglionic plexi ablation

Sites where ganglionix plexi have been found will be ablated.

Intervention Type PROCEDURE

Substrate ablation

Areas of rate dependent conduction velocity slowing will be targeted using cathether ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Able and willing to provide written informed consent
* Age: 18 years or older
* Clinical diagnosis: Persistent atrial fibrillation
* Treatment status: Scheduled to undergo first-time catheter ablation for persistent AF

Exclusion Criteria

* Inability or unwillingness to provide informed consent
* Under 18 years of age
* Previous left atrial ablation for AF or other atrial arrhythmias
* Any clinical contraindications to undergoing AF catheter ablation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Bartholomew's Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Shohreh Honarbakhsh, MBBS, MRCP, PhD

Role: CONTACT

02037658682

Sayed Al-Aidarous, MBBS, MRCP

Role: CONTACT

Other Identifiers

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407

Identifier Type: -

Identifier Source: org_study_id

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