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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Device: Atrial Fibrillation Radiofrequency Ablation Only

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime Zabern, MD; Phone Number: +972-54-5644963; Email: maximz@shamir.gov.il
• Study Contact Backup: Name: Ofir Mitz; Email: ofirm@shamir.gov.il

Study Locations

• Israel
  • Be’er Ya‘aqov, Israel
    • Recruiting
    • Shamir Medical Center
    • Contact: Maxime Zabern, MD; Phone Number: +972-54-5644963; Email: maximz@shamir.gov.il
    • Contact: Ofir Mitz; Email: ofirm@shamir.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Comparison between two mapping catheters, Optrell vs Octaray, in the same patient	Device: Atrial Fibrillation Radiofrequency Ablation Only; Comparison between two mapping catheters, Optrell vs Octaray, in the same patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance	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.	During ablation procedure
Workflow Efficiency	Difference in time (in minutes) required to confirm conduction block status using the Optrell vector method versus full activation mapping.	During ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bipolar Voltage Correlation	Statistical correlation and evaluation of systematic bias (limits of agreement) between the bipolar voltage amplitudes recorded by the two catheters in matched anatomical regions.	During ablation procedure
Multipolar Voltage Correlation	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.	During ablation procedure
Clinical Efficacy	Freedom from any documented atrial tachyarrhythmia lasting ≥30 seconds at 1, 3, 6, 9, and 12 months	12 month follow up period

Collaborators and Investigators

• Sponsor: Maxime Zabern
• Investigators: Principal Investigator: Maxime Zabern, MD, Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: Optrell vs Octaray

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes