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Substrate Remodelling and Targeted Ablation in AF

Sponsor: Barts & The London NHS Trust

NCT ID: NCT07047235

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pulmonary vein reisolation (procedure), Ganglionic plexi ablation (procedure), Substrate ablation (procedure)
How long the study runs
Study runs about 57 months (dates as stated)
About the drug or intervention
Pulmonary vein reisolation — procedure: The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated. · Ganglionic plexi ablation — procedure: Sites where ganglionix plexi have been found will be ablated. · Substrate ablation — procedure: Areas of rate dependent conduction velocity slowing will be targeted using cathether ablation
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
160
Started
2025-11-07
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation (af)
  • • NA - 160 participants
  • • Atrial fibrillation (AF) is the most common heart rhythm disorder, affecting millions worldwide and causing symptoms such as palpitations, fatigue and breathlessness

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with atrial fibrillation (af)

Where?

  • • London - St Bartholomew's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Atrial Fibrillation (AF)Atrial Fibrillation MechanismsCatheter AblationLow Voltage Areas

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Able and willing to provide written agreement to take part
  • ✓Age: 18 years or older
  • ✓Clinical diagnosis: Persistent atrial fibrillation
  • ✓Treatment status: Scheduled to undergo first-time catheter ablation for persistent AF

Who cannot take part

  • ✗Inability or unwillingness to provide agreement to take part
  • ✗Under 18 years of age
  • ✗Previous left atrial ablation for AF or other atrial arrhythmias
  • ✗Any clinical contraindications to undergoing AF catheter ablation
See the full criteria
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

Where Is This Study? (1 UK site)

St Bartholomew's Hospital

London, United Kingdom

Recruiting

How to Get in Touch

Shohreh Honarbakhsh, MBBS, MRCP, PhD

Sponsor contact

CONTACT

02037658682 shohreh.honarbakhsh@nhs.net

Sayed Al-Aidarous, MBBS, MRCP

Sponsor contact

CONTACT

sayed.al-aidarous@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-11