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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Persistent atrial fibrillation with clinical indication for catheter ablation

• Clinically suitable candidate for catheter ablation

• Signed informed consent

Locations
Other Locations
United Kingdom
Hammersmith Hospital
RECRUITING
London
Contact Information
Primary
Prapa Kanagaratnam, FRCP PhD
p.kanagaratnam@imperial.ac.uk
‭020 3312 6666‬
Backup
Oliver S Jones, MRCP
o.jones@imperial.ac.uk
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-10
Participants
Target number of participants: 110
Treatments
Placebo_comparator: Pulmonary vein isolation with diagnostic RETRO-Mapping only
All patients will undergo standard pulmonary vein isolation (PVI) procedures with 3D electroanatomic mapping using the CARTO™ system (Biosense Webster, USA), or the EnSite X™ system (Abbott, USA). A decapolar catheter will be inserted into the coronary sinus. A 3D electroanatomic map of the left atrium will be created and all pulmonary veins will be identified. Radio-frequency ablation will be performed to achieve PVI.~After the PVI procedure, patients in the control arm will have the same mapping for identification and categorisation of focal sources, but no adjunctive ablation. RETRO-Mapping will be performed using custom-built hardware called Tau20 that has been validated for reproducibility against existing commercial technologies.
Experimental: Pulmonary vein isolation with adjunctive ablation guided by RETRO-Mapping
In addition to and after the PVI procedure, patients the intervention arm will then have RETRO-Mapping performed of the remaining atria and atrial fibrillation cycle length measured in coronary sinus and left atrial appendage. Each segment will be mapped for 30 seconds and the activation pattern categories; if focal activation is identified, it will then be ablated. A further 30 seconds will be mapped at the same segments post-ablation to determine effect. The coronary sinus and left atrial appendage cycle length will be documented at the start of RETRO-Mapping and after each lesion set.
Related Therapeutic Areas
Sponsors
Collaborators: Imperial College Healthcare NHS Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov