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Clinical Trials in Israel / NCT07563257
Recruiting Not applicable

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

NCT07563257 · tracked via the Priya Life Science Israel tracker
Sponsor
Maxime Zabern
Phase
Not applicable
Started
2026-05-12
Last updated
2026-06-03

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

Atrial Fibrillation Radiofrequency Ablation Only

Atrial Fibrillation Radiofrequency Ablation Only: Comparison between two mapping catheters, Optrell vs Octaray, in the same patient

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shamir Medical Center Be’er Ya‘aqov Israel Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563257 on ClinicalTrials.gov ↗ ← All trials in Israel