Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402617
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
Ablation of Focal Activation in Atrial Fibrillation
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Ablation of Focal Activation During Persistent Atrial Fibrillation to Determine the Characteristics of Focal Drivers
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRO-AF
Brief 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
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
Detailed Description:
Multiple large prospective randomised controlled trials have shown that pulmonary vein isolation PVI terminates AF in 50-70 of cases The continued presence of atrial fibrillation AF in those without demonstrable reconnection on a mapping catheter suggests other mechanisms at play However outside PV ectopy drivers of AF initiation or maintenance remain unclear
Detailed mapping studies have confirmed the presence of both focal activation and spatiotemporally stable planar wavefronts during AF with limited data suggesting focal activation may drive AF This study is based on the hypothesis that focal activation may lead to planar wavefronts at its origin which subsequently disintegrate on exposure to refractory myocardium in different locations and assumes that randomised studies of adjunctive ablation have shown poor results to date because excessive ablation has been performed at non-driver sites and this ablation scar is pro-arrhythmic
RETRO-Mapping is a novel algorithmic solution to AF mapping with published validation confirming accuracy of analysis of activation wavefronts when benchmarked against laborious manual annotation RETRO-Mapping found that nearly 30 of mapped sites contained focal activation and these ranged from single events to repetitive events that could either be consecutive or interspersed with other activation patterns This study now aims to characterise multiple different activation patterns that exist within the milieu of AF and interrogate their role in the initiation and maintenance of AF by randomising patients to adjunctive ablation of sites of focal activation versus usual care alone ie PVI
The effect of this adjunctive ablation on AF cycle length will be the primary outcome measure and freedom from AF will be a secondary outcome measure AF termination is usually considered a positive endpoint for adjunctive ablation but as a single event cannot help identify which part of the adjunctive ablation approach led to this useful outcome By contrast left atrial appendage and coronary sinus cycle length prolongation can be used as continuous measures of progress towards AF termination and may allow determination of whether focal activation sites are drivers of persistent AF and whether the characteristics of focal activation alter the likelihood of it being a driver
Detailed mapping studies have confirmed the presence of both focal activation and spatiotemporally stable planar wavefronts during AF with limited data suggesting focal activation may drive AF This study is based on the hypothesis that focal activation may lead to planar wavefronts at its origin which subsequently disintegrate on exposure to refractory myocardium in different locations and assumes that randomised studies of adjunctive ablation have shown poor results to date because excessive ablation has been performed at non-driver sites and this ablation scar is pro-arrhythmic
RETRO-Mapping is a novel algorithmic solution to AF mapping with published validation confirming accuracy of analysis of activation wavefronts when benchmarked against laborious manual annotation RETRO-Mapping found that nearly 30 of mapped sites contained focal activation and these ranged from single events to repetitive events that could either be consecutive or interspersed with other activation patterns This study now aims to characterise multiple different activation patterns that exist within the milieu of AF and interrogate their role in the initiation and maintenance of AF by randomising patients to adjunctive ablation of sites of focal activation versus usual care alone ie PVI
The effect of this adjunctive ablation on AF cycle length will be the primary outcome measure and freedom from AF will be a secondary outcome measure AF termination is usually considered a positive endpoint for adjunctive ablation but as a single event cannot help identify which part of the adjunctive ablation approach led to this useful outcome By contrast left atrial appendage and coronary sinus cycle length prolongation can be used as continuous measures of progress towards AF termination and may allow determination of whether focal activation sites are drivers of persistent AF and whether the characteristics of focal activation alter the likelihood of it being a driver
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRAS Project ID 328297 | OTHER | UK Integrated Research Application System | None |