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Ablation of Focal Activation in Atrial Fibrillation

Sponsor: Imperial College London

NCT ID: NCT06402617

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pulmonary vein isolation (procedure), RETRO-Mapping without adjunctive ablation (diagnostic test), Adjunctive ablation guided by RETRO-Mapping (procedure)
How long the study runs
Study runs about 30 months (dates as stated)
About the drug or intervention
Pulmonary vein isolation — procedure: 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: Radio-frequency ablation using a European conformity (CE)-marked ablation catheter of sites of focal activation identified by RETRO-Mapping
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 85 Years
Who
All
Number of participants
110
Started
2024-04-30
Last checked
2024-05

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation
  • • NA - 110 participants
  • • Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF)

Who can take part?

  • • Ages 18 Years to 85 Years
  • • Diagnosed with atrial fibrillation

Where?

  • • London - Hammersmith Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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 (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.

Atrial FibrillationAtrial Fibrillation, PersistentArrhythmiaArrhythmias, CardiacCardiac Arrhythmia

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 85 Years
  • Who can join: All genders

What the study is looking for

  • ✓Persistent atrial fibrillation with clinical indication for catheter ablation
  • ✓Clinically suitable candidate for catheter ablation
  • ✓Signed agreement to take part

Who cannot take part

  • ✗Previous atrial fibrillation or other catheter ablation procedure
  • ✗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...
  • ✗Any form of cardiomyopathy
  • ✗Active infection or fever
See the full criteria
Inclusion Criteria: * Persistent atrial fibrillation with clinical indication for catheter ablation * Clinically suitable candidate for catheter ablation * Signed informed consent Exclusion Criteria: * 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 * 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

Where Is This Study? (1 UK site)

Hammersmith Hospital

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Oliver S Jones, MRCPo.jones@imperial.ac.uk

How to Get in Touch

Prapa Kanagaratnam, FRCP PhD

Sponsor contact

CONTACT

‭020 3312 6666‬ p.kanagaratnam@imperial.ac.uk

Oliver S Jones, MRCP

Sponsor contact

CONTACT

o.jones@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-05