Ablation of Focal Activation in Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorImperial College London

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Persistent atrial fibrillation with clinical indication for catheter ablation

Clinically suitable candidate for catheter ablation

Signed informed consent

Disqualifiers

Previous atrial fibrillation or other catheter ablation procedure

Clinical contraindication to catheter ablation or general anaesthetic, including history of adverse reaction to contrast media, or presence of intracardiac thrombus, or inadequate anticoagulation in the preceding 6 weeks

Valvular disease graded moderate or greater, or presence of a prosthetic valve

Moderate-to-severe heart failure, defined as left ventricular ejection fraction <35% and/or New York Heart Association class III-IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary vein isolation

    Procedure/Surgery

    Standard clinical radio-frequency ablation isolation of pulmonary veins

  • RETRO-Mapping without adjunctive ablation

    Diagnostic test

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

  • Adjunctive ablation guided by RETRO-Mapping

    Procedure/Surgery

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Pulmonary vein isolation with diagnostic RETRO-Mapping onlyPlacebo comparator 2 interventions
Group B: Pulmonary vein isolation with adjunctive ablation guided by RETRO-MappingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Atrial fibrillation cycle length in coronary sinus and left atrial appendage

Measurement of atrial fibrillation cycle length in coronary sinus and left atrial appendage, measured in miliseconds

Time frame
Intra-procedural

Secondary outcomes

1

Freedom from atrial fibrillation

Follow-up after a 3-month blanking period. Recurrence of atrial arrhythmia at 3, 6, 9, and 12 months with a 24-hour Holter monitor, or at any point over same period with an AliveCor KardiaMobile, will be recorded. Measurements across differing devices will be aggregated to give a single time-to-recurrence measurement, given in days.

Time frame
1 year

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator