Atrial TachycardiaOCTOPUS-ATNCT05765565
Comparison Between the Octaray and Pentaray Catheters in Patients Undergoing Ablation for Atrial Tachycardia.
A study testing Octaray multi-electrode catheter and Pentaray multi-electrode catheter in people with Atrial Tachycardia, run by Erasmus Medical Center.
Trial summary
The goal of this randomized clinical trial is to compare the 3D electroanatomical activation map-quality and -efficiency in patients undergoing atrial tachycardia (AT) catheter ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Tachycardia
- What is being tested?
- Octaray multi-electrode catheter and Pentaray multi-electrode catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2023to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Planned for catheter ablation of either left- or right-atrium AT/flutter will be eligible for inclusion. In the group of right atrium AT patients with typical flutters will also be eligible for inclusion.
Who cannot join
- Individuals not able to provide informed consent for any reason including language and mental disabilities
Trial locations and contacts
No sites are listed yet.
Tamas Szili-Torok, MD PhD contact
About this study
Official title: Comparison Between the Multi-electrode Octaray and Pentaray Catheters in Patients Undergoing Ablation for Atrial Tachycardia Using Coherent Mapping.
The goal of this randomized clinical trial is to compare the 3D electroanatomical activation map-quality and -efficiency in patients undergoing atrial tachycardia (AT) catheter ablation. Primary objective of the study is to contrast CARTO-Coherent mapping quality (electrograms per map) using Octaray versus Pentaray catheter for left and right atrium ATs, separately.
Participants will be randomized with 1:1 ratio for undergoing 3D anatomy map with either Octaray (intervention group) or Pentaray (control) group. Next, all patients will undergo activation map of the AT with both catheters. For ablation in the intervention group, the Ocatray made activation map of the AT will be used, and the Pentary made AT activation map will be used in the control group.
Read the detailed description
This is a randomized open-label cross-over trial including consecutive patients undergoing ablation for atrial tachycardia of the left and right atrium. The sample-sizes of the left (N=20) and right (N=20) atrium will be equal. Half of the eligible patients with either left or right atrium AT will be randomized to undergo Coherent Mapping with Pentaray catheter first followed by Coherent Mapping with the Octaray catheter. The other half will undergo initial Coherent Mapping with the Octaray catheter followed by Pentaray catheter. This way all study participants (total N=40) will undergo the Coherent Mapping with both catheters (Figure 1). Only the second map created with either Octaray (n active arm left atrium =10 and n active arm right atrium =10) or Pentaray (n control arm left atrium =10 and n control arm right atrium =10) will be used for the subsequent ablation procedure.
The main outcome of the trial is the performance of the Coherent Mapping quality (electrograms per map) with Octaray catheter versus Pentaray catheter for left and right atrium, separately. A map will be considered complete when the fill threshold reach 5 mm for the entire surface area of the left or right atrium, that is the interpolation between points will be <5 mm as previously reported. The high- and low-pass filters settings will be harmonized between the catheters. The following data will be collected: 1) number of electrograms per map; 2) Voltage based signal-to-noise ratio (vSNR),17 calculated as the ratio between the mean of the peak-to-peak amplitude of the true local bipolar atrial signals and the mean of the SD of the peak-to-peak of all other signals considered as far-field or ambient lab noise; 3) electrograms acquisition rate (i.e., the acquired number of points per minute of mapping); 4) electrograms acquisition density (i.e., the acquired number of electrograms per cm2 of the left or right atrium); 5) number of electrograms acquired per beat; 6) the total ablation and fluoroscopy times; 7) acute mapping success rate, defined as termination of AT at the target region; 8) number of entrainments attempted and the best post-pacing interval value at the ablation site when available. Successful entrainment is sometimes not possible (i.e., focal AT) and some investigator may prefer not to entrain. Therefore, the decision to use entrainment and the number of entrainment attempts will be left to the discretion of the operator.
- Conditions
- Atrial Tachycardia
- Being tested
- Octaray multi-electrode catheter, Pentaray multi-electrode catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octaray multi-electrode catheterDevice
Newly designed multi-electrode catheter for creating 3D electroanatomical CARTO maps.
Pentaray multi-electrode catheterDevice
Current standard multi-electrode catheter for creating 3D electroanatomical CARTO maps.
| Study group | Role | What they receive |
|---|---|---|
| Octaray (intervention) | Experimental | Octaray created 3D map quality Receives: Device: Octaray multi-electrode catheter |
| Pentaray (control) | Active comparator | Pentaray created 3D map quality Receives: Device: Pentaray multi-electrode catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of electrograms per map
Measured: during procedure
Secondary outcomes (7)
Voltage based signal-to-noise ratio.
Measured: during procedure
electrograms acquisition rate
the acquired number of points per minute of mapping)
Measured: during procedure
electrogram acquisition density
the acquired number of electrograms per cm2 of the left or right atrium
Measured: during procedure
number of electrograms acquired per beat
Measured: during procedure
the total ablation and fluoroscopy times
Measured: during procedure
acute mapping success rate
defined as termination of AT at the target region
Measured: during procedure
number of entrainments attempted and the best post-pacing interval value at the ablation site
May not be available especially in focal AT's
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start21 Mar 2023 (estimated)
- Primary completion21 Mar 2024 (estimated)
- Study completion21 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial TachycardiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Szili-Torok, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765565
- Sponsor's protocol ID
- MEC-2022-0269
- Acronym
- OCTOPUS-AT
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Needs to be discussed with the catheter manufacturer
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Multi-electrode Octaray and Pentaray Catheters in Patients Undergoing Ablation for Atrial Tachycardia Using Coherent Mapping.
- ClinicalTrials.gov ID
- NCT05765565
- Acronym / sponsor ID
- OCTOPUS-AT / MEC-2022-0269
- Conditions
- Atrial Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2023 (estimated)
- Primary completion
- 21 Mar 2024 (estimated)
- Study completion
- 21 Mar 2024 (estimated)
- First posted
- 13 Mar 2023 (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.
The goal of this randomized clinical trial is to compare the 3D electroanatomical activation map-quality and -efficiency in patients undergoing atrial tachycardia (AT) catheter ablation. Primary objective of the study is to contrast CARTO-Coherent mapping quality (electrograms per map) using Octaray versus Pentaray catheter for left and right atrium ATs, separately.
Participants will be randomized with 1:1 ratio for undergoing 3D anatomy map with either Octaray (intervention group) or Pentaray (control) group. Next, all patients will undergo activation map of the AT with both catheters. For ablation in the intervention group, the Ocatray made activation map of the AT will be used, and the Pentary made AT activation map will be used in the control group.
Detailed description
This is a randomized open-label cross-over trial including consecutive patients undergoing ablation for atrial tachycardia of the left and right atrium. The sample-sizes of the left (N=20) and right (N=20) atrium will be equal. Half of the eligible patients with either left or right atrium AT will be randomized to undergo Coherent Mapping with Pentaray catheter first followed by Coherent Mapping with the Octaray catheter. The other half will undergo initial Coherent Mapping with the Octaray catheter followed by Pentaray catheter. This way all study participants (total N=40) will undergo the Coherent Mapping with both catheters (Figure 1). Only the second map created with either Octaray (n active arm left atrium =10 and n active arm right atrium =10) or Pentaray (n control arm left atrium =10 and n control arm right atrium =10) will be used for the subsequent ablation procedure.
The main outcome of the trial is the performance of the Coherent Mapping quality (electrograms per map) with Octaray catheter versus Pentaray catheter for left and right atrium, separately. A map will be considered complete when the fill threshold reach 5 mm for the entire surface area of the left or right atrium, that is the interpolation between points will be <5 mm as previously reported. The high- and low-pass filters settings will be harmonized between the catheters. The following data will be collected: 1) number of electrograms per map; 2) Voltage based signal-to-noise ratio (vSNR),17 calculated as the ratio between the mean of the peak-to-peak amplitude of the true local bipolar atrial signals and the mean of the SD of the peak-to-peak of all other signals considered as far-field or ambient lab noise; 3) electrograms acquisition rate (i.e., the acquired number of points per minute of mapping); 4) electrograms acquisition density (i.e., the acquired number of electrograms per cm2 of the left or right atrium); 5) number of electrograms acquired per beat; 6) the total ablation and fluoroscopy times; 7) acute mapping success rate, defined as termination of AT at the target region; 8) number of entrainments attempted and the best post-pacing interval value at the ablation site when available. Successful entrainment is sometimes not possible (i.e., focal AT) and some investigator may prefer not to entrain. Therefore, the decision to use entrainment and the number of entrainment attempts will be left to the discretion of the operator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octaray (intervention) | Experimental | Device: Octaray multi-electrode catheterOctaray created 3D map quality |
| Pentaray (control) | Active comparator | Device: Pentaray multi-electrode catheterPentaray created 3D map quality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Planned for catheter ablation of either left- or right-atrium AT/flutter will be eligible for inclusion. In the group of right atrium AT patients with typical flutters will also be eligible for inclusion.
Key exclusion criteria (1 listed)
- Individuals not able to provide informed consent for any reason including language and mental disabilities
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 |
|---|---|---|
| Octaray multi-electrode catheterNewly designed multi-electrode catheter for creating 3D electroanatomical CARTO maps. | Device | Octaray (intervention) |
| Pentaray multi-electrode catheterCurrent standard multi-electrode catheter for creating 3D electroanatomical CARTO maps. | Device | Pentaray (control) |
Primary outcome
Number of electrograms per map
Time frame: during procedure
7 secondary outcomes
Voltage based signal-to-noise ratio.
Time frame: during procedure
electrograms acquisition rate
Time frame: during procedure
electrogram acquisition density
Time frame: during procedure
number of electrograms acquired per beat
Time frame: during procedure
the total ablation and fluoroscopy times
Time frame: during procedure
acute mapping success rate
Time frame: during procedure
number of entrainments attempted and the best post-pacing interval value at the ablation site
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided. Needs to be discussed with the catheter manufacturer
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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. This study is not recruiting at the moment.
Tamas Szili-Torok, MD PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Octaray multi-electrode catheter and Pentaray multi-electrode catheter in people with Atrial Tachycardia, run by Erasmus Medical Center.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bakhtawar Mahmoodi, MD PhD MPH (+31611828388, b.mahmoodi@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of electrograms per map (time frame: during procedure). 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 13 Mar 2023.