Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorAssaf-Harofeh Medical Center
Government
Locations1 site (Be’er Ya‘aqov)
StatusRecruiting
StartedMay 12, 2026
Main results expectedMay 1, 2027
Study endsMay 1, 2028
Registry record updatedJune 3, 2026
Trial IDNCT07563257 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.