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NCT Number: NCT07563257

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrial Fibrillation Radiofrequency Ablation Only

Device

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

Primary outcomes

  1. Concordance

    Time frame: 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.

  2. Workflow Efficiency

    Time frame: During ablation procedure

    Difference in time (in minutes) required to confirm conduction block status using the Optrell vector method versus full activation mapping.

Secondary outcomes

  1. Bipolar Voltage Correlation

    Time frame: 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.

  2. Multipolar Voltage Correlation

    Time frame: 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.

  3. Clinical Efficacy

    Time frame: 12 month follow up period

    Freedom from any documented atrial tachyarrhythmia lasting ≥30 seconds at 1, 3, 6, 9, and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime Zabern, MD

CONTACT

[email protected]

+972-54-5644963

Ofir Mitz

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Maxime Zabern

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 1, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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