None listed
Conditions
Brief summary
This study tests a new computer program called "Focal Finder," designed to quickly identify the precise source of certain fast heart rhythms (focal atrial tachycardia). During standard ablation procedures, locating these sources can be time-consuming, and the arrhythmia sometimes stops before a complete map is obtained. Focal Finder may be able to pinpoint the source from only a small number of measurements. To validate accuracy, researchers pace the heart from known locations during procedures that patients are already undergoing for clinical reasons. Because the exact pacing location is known, the team can measure how accurately the algorithm identifies it. The research component (additional pacing sequences) is performed after the clinical procedure is completed, before catheters are removed, and adds approximately 20–40 minutes. No additional procedures, needle insertions, or drugs are involved.
Interventions
This study involves systematic atrial pacing and electroanatomic mapping performed as an adjunct to clinically indicated electrophysiology (EP) procedures. After completion of the standard clinical EP procedure and prior to catheter removal, the research component is undertaken. This consists of:
1. Systematic pacing of predefined atrial sites in all patients [High Crista Terminalis,Low Crista Terminalis, Tricuspid Annulus , Septum, AV Node, Coronary Sinus Ostium, Superior Tricuspid Annulus, Ri
This study involves systematic atrial pacing and electroanatomic mapping performed as an adjunct to clinically indicated electrophysiology (EP) procedures. After completion of the standard clinical EP procedure and prior to catheter removal, the research component is undertaken. This consists of: 1. Systematic pacing of predefined atrial sites in all patients [High Crista Terminalis,Low Crista Terminalis, Tricuspid Annulus , Septum, AV Node, Coronary Sinus Ostium, Superior Tricuspid Annulus, Right Atrial Appendage] using standard intracardiac catheters already in situ [HD Advisor, Ablation catheter, Coronary Sinus Catheter). 2. Recording of intracardiac electrograms and electroanatomic data during each pacing sequence. 3. Analysis of the recorded activation signals using the investigational Focal Finder software algorithm, which applies a geodesic focal source localisation approach to estimate the pacing origin. This can be performed offline after the procedure OR live during the procedure on a separate computer not used in the clinical procedure. If used live during the procedure, this is only used for data acquisition workflow simplification and does not affect the clinical procedure. Because the true pacing location is known, algorithm predictions can be compared against ground truth, allowing validation of localisation accuracy. Additional notes: 1. Focal Finder will preferentially be performed live during electrophysiology studies. The protocol allows for the acccuracy of the algorithm to be evaluated on recorded protocol data for a run in period of 10 patients at the start of the study. 2. Electrogram durations in are typically 10-20ms with standard filter settings 3. Total duration of the mapping protocol is anticipated to take 20 minutes for the pacing simulation study.
Sponsors
Southern Adelaide Local Health Network (Flinders Medical Centre)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years or older. • Undergoing a clinically indicated EP procedure (including but not limited to: supraventricular tachycardia ablation, atrial flutter ablation, atrial fibrillation ablation, ventricular ectopy ablation, or diagnostic EP study). • Sinus rhythm present or achievable during the research component of the procedure. • Willing and able to provide written informed consent. • Electroanatomic mapping with Abbott EnSiteX planned as part of or amendable to the clinical procedure.
Exclusion criteria
• Spontaneous sustained atrial tachycardia or atrial flutter during the research component that cannot be terminated. • Haemodynamic instability precluding research pacing protocol. • Inability to obtain an adequate electroanatomic shell of the atrium (either right or left, as applicable). • Pregnant or breastfeeding women. • Unable to provide informed consent (e.g., language barrier without interpreter, cognitive impairment). • Requirement for emergency intervention precluding research activities.
Outcome results
None listed