Atrial Fibrillation Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • 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.

Locations
Other Locations
Israel
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Contact Information
Primary
Maxime Zabern, MD
maximz@shamir.gov.il
+972-54-5644963
Backup
Ofir Mitz
ofirm@shamir.gov.il
Time Frame
Start Date: 2026-05-12
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 30
Treatments
Other: Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
Related Therapeutic Areas
Sponsors
Leads: Maxime Zabern

This content was sourced from clinicaltrials.gov