Ablation of Focal Activation in Atrial Fibrillation

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.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Arrhythmia
• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Interventions

PROCEDURE

Pulmonary vein isolation

Standard clinical radio-frequency ablation isolation of pulmonary veins

DIAGNOSTIC_TEST

RETRO-Mapping without adjunctive ablation

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

PROCEDURE

Adjunctive 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Prapa Kanagaratnam, FRCP PhD · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-30

Primary Completion

2025-10-31

Completion

2026-10-31

Countries

• United Kingdom

Study Locations