Substrate Remodelling and Targeted Ablation in AF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary vein reisolation, Ganglionic plexi ablation, Substrate ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Atrial Fibrillation Mechanisms, Catheter Ablation, Low Voltage Areas. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Understanding Substrate Evolution in Persistent Atrial Fibrillation to Develop Tailored Ablation Strategies
Overview
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.
Interventions
- Procedure Pulmonary vein reisolation
The pulmonary veins will be checked electrically and further ablation will be undertaken if they are not isolated. - Procedure Ganglionic plexi ablation
Sites where ganglionix plexi have been found will be ablated. - Procedure Substrate ablation
Areas of rate dependent conduction velocity slowing will be targeted using cathether ablation
Primary outcome measures
- Assessment of Electrical, Structural and Autonomic Remodelling in Persistent Atrial Fibrillation [Time frame: 4 years]
- Establish a Predictive Model to Idenitfy Which Patients are Responders to Pulmonary Vein Isolation Alone and Who Will Require Further Tailored Ablation Strategies [Time frame: 24 months]
- To Assess if Ablation of Rate Dependent Conduction Velocity Slowing Sites Improves Freedom from Atrial Fibrillation [Time frame: 5 years]
Secondary outcome measures (1)
- Develop Personalised Electrical Atrial Models [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- St Bartholomew's Hospital — London
Identifiers
NCT: NCT07047235 · 407