Atrial Fibrillation (AF)NCT07563257
Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
A study testing Atrial Fibrillation Radiofrequency Ablation Only in people with Atrial Fibrillation (AF), run by Maxime Zabern at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Atrial Fibrillation Radiofrequency Ablation Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 12 May 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ofir Mitz contact
Israel1 site, 1 recruiting
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov
Maxime Zabern, MD, +972-54-5644963, maximz@shamir.gov.il
Ofir Mitz, ofirm@shamir.gov.il
About this study
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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Atrial Fibrillation Radiofrequency Ablation Only
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Fibrillation Radiofrequency Ablation OnlyDevice
Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
| Study group | Role | What they receive |
|---|---|---|
| Comparison between two mapping catheters, Optrell vs Octaray, in the same patient | Other | Not described Receives: Device: Atrial Fibrillation Radiofrequency Ablation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During ablation procedure
Secondary outcomes (3)
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.
Measured: During ablation procedure
Multipolar Voltage Correlation
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.
Measured: During ablation procedure
Clinical Efficacy
Freedom from any documented atrial tachyarrhythmia lasting ≥30 seconds at 1, 3, 6, 9, and 12 months
Measured: 12 month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start12 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxime Zabern
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Maxime Zabern, Assaf-Harofeh Medical Center
- Investigators
- Maxime Zabern, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563257
- Sponsor's protocol ID
- Optrell vs Octaray
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
- ClinicalTrials.gov ID
- NCT07563257
- Acronym / sponsor ID
- Optrell vs Octaray
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxime ZabernOther government
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison between two mapping catheters, Optrell vs Octaray, in the same patient | Other | Device: Atrial Fibrillation Radiofrequency Ablation Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • 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.
Key exclusion criteria (5 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial Fibrillation Radiofrequency Ablation OnlyComparison between two mapping catheters, Optrell vs Octaray, in the same patient | Device | Comparison between two mapping catheters, Optrell vs Octaray, in the same patient |
Primary outcome
Concordance
Time frame: During ablation procedure
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.
Workflow Efficiency
Time frame: During ablation procedure
Difference in time (in minutes) required to confirm conduction block status using the Optrell vector method versus full activation mapping.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ofir Mitz contact
Maxime Zabern, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial Fibrillation Radiofrequency Ablation Only in people with Atrial Fibrillation (AF), run by Maxime Zabern at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime Zabern, MD (+972-54-5644963, maximz@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance (time frame: During ablation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.