RecruitingNot ApplicableNCT06402617

Ablation of Focal Activation in Atrial Fibrillation

Ablation of Focal Activation During Persistent Atrial Fibrillation to Determine the Characteristics of Focal Drivers


Sponsor

Imperial College London

Enrollment

110 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF). However, it has not been possible to show similar focal drivers during AF, owing to the limitations of mapping in persistent AF. RETRO-Mapping has been developed as a method to generate activation maps during AF to test the hypothesis that persistent AF is also maintained by focal drivers. RETRO-Mapping is able to locate sites of focal activation that were isolated, intermittent, or recurrent during persistent AF. However, a 30-second segment of AF can have approximately 150 wavefronts in a small area of myocardium. Screening for focal activation and manually validating these prior to ablation was not feasible using current commercial systems. RETRO-Mapping can automatically detect focal activation and a recording system that enables the intracardiac signals to be directly analysed by the RETRO-Mapping software. This will allow RETRO-Mapping to build a detailed classification of focal activation types and study the impact of ablation of these sites on the AF cycle length, to address the hypothesis that persistent AF is maintained by focal drivers.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a catheter-based heart procedure (ablation) that targets specific electrical "hot spots" in patients with persistent atrial fibrillation (an irregular heartbeat that doesn't stop on its own) to see if it can restore normal rhythm. **You may be eligible if...** - You have persistent atrial fibrillation and your doctor has recommended a catheter ablation procedure - You are a suitable candidate for the procedure based on your overall health - You have not had a previous ablation procedure for atrial fibrillation **You may NOT be eligible if...** - You have a blood clot inside your heart, or your blood thinning has not been adequate recently - You have moderate to severe heart valve disease or a prosthetic heart valve - You have moderate to severe heart failure (ejection fraction below 35% or NYHA class III-IV) - You have any form of cardiomyopathy (disease of the heart muscle) - You have uncontrolled diabetes, a serious infection, severe kidney disease, or active gastrointestinal bleeding - You are pregnant or could be pregnant - You have a serious bleeding or clotting disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPulmonary vein isolation

Standard clinical radio-frequency ablation isolation of pulmonary veins

DIAGNOSTIC_TESTRETRO-Mapping without adjunctive ablation

RETRO-Mapping performed using research equipment and software, but without any adjunctive ablation

PROCEDUREAdjunctive ablation guided by RETRO-Mapping

Radio-frequency ablation using a European conformity (CE)-marked ablation catheter of sites of focal activation identified by RETRO-Mapping


Locations(1)

Hammersmith Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06402617


Related Trials