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N/A N=31 Basic Science

Characterising the Stable and Dynamic Left Atrial Substrate in Atrial Fibrillation

Atrial Fibrillation

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: To Define the Normal Range of Voltage Amplitude — 2.00; 1.92 mV

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
High density electrophysiological mapping (Diagnostic_test); Cardiac Magnetic Resonance Imaging (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oxford University Hospitals NHS Trust
Primary completion
Nov 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
To Define the Normal Range of Voltage Amplitude
2.00; 1.92
SECONDARY
Effect of Pacing Cycle Length on Electrogram Morphology
SECONDARY
Effect of Pacing Cycle Length on Conduction Velocity
SECONDARY
To Compare Electroanatomic Voltage Mapping (EAVM) Performed With a Bipolar Contact Force Guided Ablation Catheter to the Abbott HD Grid Using Orthogonal Wave Analysis in Sinus Rhythm.
SECONDARY
To Evaluate the Distribution of Late Gadolinium Enhancement on Cardiac MRI Relative to Electrogram Amplitude Identified Using the HD Grid
SECONDARY
To Evaluate the Distribution of Electrogram Morphologies Relative to Late Gadolinium Enhancement on Cardiac MRI
SECONDARY
To Evaluate the Effect of Cycle Length on Conduction Velocities Relative to Distribution of Late Gadolinium Enhancement on Cardiac MRI

Summary

Atrial fibrillation (AF) is the most common sustained arrhythmia, with increasing prevalence associated with an ageing population. Management is challenging, and invasive catheter ablation procedures are increasingly used in those with symptoms refractory to drug therapy. Unfortunately, success rates from this procedure can be limited. This is partly due to limitations in understanding of the mechanisms involved in arrhythmia propagation. There is much interest in the role of structural changes within the muscle of the left atrium resulting in scaring (known as fibrosis). This has been identified on MRI studies and invasive electroanatomical mapping using voltage amplitude of recorded signals as a surrogate measure of tissue properties. This however is affected by the technology used, as it does not routinely incorporate the effect of heart rate on conduction properties. Furthermore, although this aims to identify regions of structural changes, it does not identify more dynamic patterns of conduction seen during AF. This study aims to use a high density mapping catheter (Abbott Advisa HD grid (SE)), which employs a novel algorithm to minimise the effect of wavefront direction on the size of electrical signals. Electroanatomical mapping of the left atrium in patients with atrial fibrillation will be conducted whilst pacing at long and short cycle lengths to assess the effect of pacing rate on conduction properties, assessed using signal morphology and conduction velocity. The same procedure will also be carried out in 5 control patients to allow comparison with normal atria. Two subgroups will also analysed. In the first the aim is to compare the use of the HD grid catheter to a bipolar ablation catheter in carrying out electroanatomical mapping. In the second, to correlate electrical signals obtained with propagation patterns identified using the AcQMap non-contact mapping system and atrial properties identified on cardiac MRI.

Eligibility Criteria

Inclusion Criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter ablation procedure (AF ablation group only).
  • Undergoing elective left sided catheter ablation procedure involving a trans-septal approach (Control group only).
  • In the Investigator's opinion the participant is able and willing to comply with all trial requirements.

Exclusion Criteria

  • Previous cardiac surgery.
  • Previous left atrial ablation (catheter or surgical).
  • Medical history including any of: atrial fibrillation, atrial flutter, hypertension, diabetes mellitus, chronic obstructive pulmonary disease, significant mitral valve disease (stenosis or regurgitation), pulmonary hypertension, obstructive sleep apnoea, ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, structural heart disease (excluding known accessory pathway), congenital cardiac anomaly (excluding accessory pathway), previous left atrial ablation (catheter or surgical), cardiac surgery (control group only).
  • Contraindications to MR scanning (such as metallic or electronic objects implanted in your body or history of severe claustrophobia) (AcQMap guided ablation group).
  • Significantly impaired renal function (eGFR<30ml/min).
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
  • Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks. (Involvement in any other research trial is not a contraindication per se).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04229472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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