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

NCT07563257 | Not Yet Recruiting FDA Device

• 1 other identifier: Optrell vs Octaray
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Bipolar Voltage Correlation

  During ablation procedure

• Multipolar Voltage Correlation

  During ablation procedure

• Clinical Efficacy

  12 month follow up period

Study Arms (1)

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

OTHER

Device: Atrial Fibrillation Radiofrequency Ablation Only

Interventions

Atrial Fibrillation Radiofrequency Ablation Only DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxime Zabern: lead

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maxime Zabern, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime Zabern, MD

CONTACT

+972-54-5644963; maximz@shamir.gov.il

Elad Anter, MD

CONTACT

+972-8-9779730; eladan@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist in Electrophysiology Unit

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IL (1)