Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atrial Fibrillation Radiofrequency Ablation Only.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device Atrial Fibrillation Radiofrequency Ablation Only
Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
Primary outcome measures
- Concordance [Time frame: During ablation procedure]
- Workflow Efficiency [Time frame: During ablation procedure]
Secondary outcome measures (3)
- Bipolar Voltage Correlation [Time frame: During ablation procedure]
- Multipolar Voltage Correlation [Time frame: During ablation procedure]
- Clinical Efficacy [Time frame: 12 month follow up period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Israel · 1 center
- Shamir Medical Center — Be’er Ya‘aqov
Identifiers
NCT: NCT07563257 · Optrell vs Octaray