RecruitingNot ApplicableNCT07563257

Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation


Sponsor

Maxime Zabern

Enrollment

30 participants

Start Date

May 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

DEVICEAtrial Fibrillation Radiofrequency Ablation Only

Comparison between two mapping catheters, Optrell vs Octaray, in the same patient


Locations(1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

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NCT07563257


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