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Not yet recruitingNCT05765565OCTOPUS-ATUpdated Mar 13, 2023

Comparison Between the Octaray and Pentaray Catheters in Patients Undergoing Ablation for Atrial Tachycardia.

An interventional study of Octaray multi-electrode catheter and Pentaray multi-electrode catheter in Atrial Tachycardia, sponsored by Erasmus Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-13.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Atrial Tachycardia

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03

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's planned enrollment of 40 is below the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Individuals not able to provide informed consent for any reason including language and mental disabilities
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Octaray (intervention)

    Octaray created 3D map quality

    Device: Octaray multi-electrode catheter

  • Active comparator
    Pentaray (control)

    Pentaray created 3D map quality

    Device: Pentaray multi-electrode catheter

Interventions

  • DeviceOctaray multi-electrode catheter

    Newly designed multi-electrode catheter for creating 3D electroanatomical CARTO maps.

  • DevicePentaray multi-electrode catheter

    Current standard multi-electrode catheter for creating 3D electroanatomical CARTO maps.

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What researchers measure

Primary outcomes

  1. Number of electrograms per map

    Time frame: during procedure

Secondary outcomes

  1. Voltage based signal-to-noise ratio.

    Time frame: during procedure

  2. electrograms acquisition rate

    the acquired number of points per minute of mapping)

    Time frame: during procedure

  3. electrogram acquisition density

    the acquired number of electrograms per cm2 of the left or right atrium

    Time frame: during procedure

  4. number of electrograms acquired per beat

    Time frame: during procedure

  5. the total ablation and fluoroscopy times

    Time frame: during procedure

  6. acute mapping success rate

    defined as termination of AT at the target region

    Time frame: during procedure

  7. number of entrainments attempted and the best post-pacing interval value at the ablation site

    May not be available especially in focal AT's

    Time frame: during procedure

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — Needs to be discussed with the catheter manufacturer

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05765565
Lead sponsor
Erasmus Medical Center
Responsible party
Tamas Szili-Torok (Dr., Erasmus Medical Center) — Principal investigator
First posted
Mar 13, 2023
Start date
Mar 21, 2023 (estimated)
Primary completion
Mar 21, 2024 (estimated)
Completion
Mar 21, 2024 (estimated)
Last update
Mar 13, 2023

Study contacts

Bakhtawar Mahmoodi, MD PhD MPH
Contact
b.mahmoodi@erasmusmc.nl
+31611828388
Tamas Szili-Torok, MD PhD
Contact
t.szilitorok@erasmusmc.nl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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