Comparison of Optrell and Octaray Mapping Catheters for Atrial Ablation
Official title: Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
Run by Assaf-Harofeh Medical Center · NCT07563257 · Data updated 2026-11-12
This study tests whether the Optrell catheter with V8 software can confirm conduction block during atrial ablation and compares voltage readings with Octaray in adults with atrial fibrillation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Be’er Ya‘aqov) |
| Status | Recruiting |
| Started | May 12, 2026 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07563257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with persistent AF or atrial flutter undergoing first-time or redo ablation that includes planned linear lesion sets, and who can provide informed consent.
✕Probably not a fit
Patients whose procedures do not involve linear lesions or who have exclusion criteria such as mechanical valves or intracardiac thrombus may not benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational study compares two high-density multielectrode mapping catheters during catheter ablation for complex atrial arrhythmias. It evaluates real-time vector propagation and the ability to confirm conduction block across ablation lines without full chamber remapping, alongside a head-to-head comparison of bipolar voltage distributions from the two catheters. The study focuses on procedural workflow efficiency and key electrophysiological metrics to determine if Optrell offers similar or improved performance relative to Octaray. Eligible participants include adults with persistent AF or atrial flutter undergoing first-time or redo ablation with planned linear lesion sets. The investigation is conducted at Shamir Medical Center under the lead sponsor Maxime Zabern.
Why it matters
Potential benefit: If successful, patients could benefit from faster, more reliable confirmation of lesion completeness and potentially more accurate voltage assessment during ablation.
How similar studies have gone: Previous work has explored high-density mapping catheters for ablation guidance, with mixed outcomes; this study adds a direct comparison of two catheter systems in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shamir Medical Center
Be’er Ya‘aqov, Israel Recruiting
Study contacts
- Principal investigator: Maxime Zabern, MD — Assaf-Harofeh Medical Center
- Study coordinator: Maxime Zabern, MD
- Email: maximz@shamir.gov.il
- Phone: +972-54-5644963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.