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

Maxime Zabern30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation (AF)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: During ablation procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: During ablation procedure

Clinical Efficacy

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

Time frame: 12 month follow up period

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts