NCT07563257 Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
| NCT ID | NCT07563257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxime Zabern |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-05-12 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Maxime Zabern, MD
PRINCIPAL INVESTIGATOR
Assaf-Harofeh Medical Center
Frequently Asked Questions
Who can join the NCT07563257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563257 currently recruiting?
Yes, NCT07563257 is actively recruiting participants. Contact the research team at maximz@shamir.gov.il for enrollment information.
Where is the NCT07563257 trial being conducted?
This trial is being conducted at Be’er Ya‘aqov, Israel.
Who is sponsoring the NCT07563257 clinical trial?
NCT07563257 is sponsored by Maxime Zabern. The principal investigator is Maxime Zabern, MD at Assaf-Harofeh Medical Center. The trial plans to enroll 30 participants.
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