Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2024-04-30
2026-10-31
Brief Summary
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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.
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Detailed Description
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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 (i.e., 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Pulmonary vein isolation
Standard clinical radio-frequency ablation isolation of pulmonary veins
RETRO-Mapping without adjunctive ablation
RETRO-Mapping performed using research equipment and software, but without any adjunctive ablation
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.
Pulmonary vein isolation
Standard clinical radio-frequency ablation isolation of pulmonary veins
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
Interventions
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Pulmonary vein isolation
Standard clinical radio-frequency ablation isolation of pulmonary veins
RETRO-Mapping without adjunctive ablation
RETRO-Mapping performed using research equipment and software, but without any adjunctive ablation
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
Eligibility Criteria
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Inclusion Criteria
* Clinically suitable candidate for catheter ablation
* Signed informed consent
Exclusion Criteria
* 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
* Any form of cardiomyopathy
* Active infection or fever
* Severe cerebrovascular disease
* Active gastrointestinal bleeding
* Bleeding or clotting disorders, clinically high bleeding risk, or clinical contraindication to receiving heparin
* Baseline serum creatinine \>200umol/L
* Currently receiving or at risk of requiring renal replacement therapy
* Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and fasting blood glucose ≥9.2mmol/L)
* Malignancy necessitating therapy
* Life expectancy shorter than the duration of the trial
* Pregnancy, or childbearing potential and not using a highly effective method of contraception
* Inability to provide informed consent to participate in the trial
18 Years
85 Years
ALL
No
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Prapa Kanagaratnam, FRCP PhD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Hammersmith Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS Project ID: 328297
Identifier Type: OTHER
Identifier Source: secondary_id
22HH8087
Identifier Type: -
Identifier Source: org_study_id
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