Atrial Fibrillation (AF)
Conditions
Brief summary
This prospective, single-center observational study aims to compare the clinical performance, workflow efficiency, and electrophysiological metrics of two commercially available, high-density multielectrode mapping catheters (Octaray and Optrell) in patients undergoing catheter ablation for complex atrial arrhythmias. The primary focus is to determine if the real-time vector propagation capabilities of the Optrell catheter combined with V8 software can accurately confirm conduction block across linear ablation lesions without the need for full-chamber activation remapping, which is the current standard of care. A secondary focus will pair-compare the bipolar voltage amplitude distributions recorded by both catheters, given their differing electrode sizes and spacing.
Interventions
Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
Sponsors
Maxime Zabern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Age ≥18 years. * • Documented persistent atrial fibrillation and/or atrial flutter. * • Undergoing a clinically indicated first-time (de novo) or redo catheter ablation where linear ablation lesion sets (e.g., posterior wall, roof line, lateral mitral line, CTI) are planned or anticipated. * • Ability to provide written informed consent.
Exclusion criteria
* • Paroxysmal or persistent AF where only standard PVI is planned. * • Mechanical mitral valve. * • Presence of intracardiac thrombus or contraindication to systemic anticoagulation. * • Any medical condition or anatomical contraindication that, in the investigator's judgment, precludes safe participation. * • Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance | During ablation procedure | Percentage of agreement (presence vs. absence of bidirectional block) between the Optrell real-time vector assessment and standard activation remapping on a per-line basis. |
| Workflow Efficiency | During ablation procedure | Difference in time (in minutes) required to confirm conduction block status using the Optrell vector method versus full activation mapping. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bipolar Voltage Correlation | During ablation procedure | Statistical correlation and evaluation of systematic bias (limits of agreement) between the bipolar voltage amplitudes recorded by the two catheters in matched anatomical regions. |
| Multipolar Voltage Correlation | During ablation procedure | Statistical correlation and evaluation of systematic bias (limits of agreement) between the multipolar voltage amplitudes recorded by the Optrell catheter and the bipolar voltage amplitudes recorded by the Octaray catheter in matched anatomical regions. |
| Clinical Efficacy | 12 month follow up period | Freedom from any documented atrial tachyarrhythmia lasting ≥30 seconds at 1, 3, 6, 9, and 12 months |
Countries
Israel
Contacts
CONTACTMaxime Zabern, MD
CONTACTOfir Mitz
PRINCIPAL_INVESTIGATORMaxime Zabern, MD
Assaf-Harofeh Medical Center
Outcome results
None listed