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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison between two mapping catheters, Optrell vs Octaray, in the same patient | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial Fibrillation Radiofrequency Ablation Only | Device | Comparison between two mapping catheters, Optrell vs Octaray, in the same patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | During ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During ablation procedure |
| Multipolar Voltage Correlation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxime Zabern, MD | Contact | +972-54-5644963 | maximz@shamir.gov.il | |
| Ofir Mitz | Contact | ofirm@shamir.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Maxime Zabern, MD | Assaf-Harofeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center | Recruiting | Be’er Ya‘aqov | Israel |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2026 | Apr 20, 2026 |
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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. |
| During ablation procedure |
| Clinical Efficacy | Freedom from any documented atrial tachyarrhythmia lasting ≥30 seconds at 1, 3, 6, 9, and 12 months | 12 month follow up period |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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