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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Bakhtawar Mahmoodi, MD PhD MPH contact

+31611828388

b.mahmoodi@erasmusmc.nl

Tamas Szili-Torok, MD PhD contact

t.szilitorok@erasmusmc.nl

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.

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 groups in NCT05765565
Study groupRoleWhat they receive
Octaray (intervention)ExperimentalOctaray created 3D map quality
Receives: Device: Octaray multi-electrode catheter
Pentaray (control)Active comparatorPentaray 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.

  1. Number of electrograms per map

    Measured: during procedure

Secondary outcomes (7)
  1. Voltage based signal-to-noise ratio.

    Measured: during procedure

  2. electrograms acquisition rate

    the acquired number of points per minute of mapping)

    Measured: during procedure

  3. electrogram acquisition density

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

    Measured: during procedure

  4. number of electrograms acquired per beat

    Measured: during procedure

  5. the total ablation and fluoroscopy times

    Measured: during procedure

  6. acute mapping success rate

    defined as termination of AT at the target region

    Measured: 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

    Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start21 Mar 2023 (estimated)
  3. Primary completion21 Mar 2024 (estimated)
  4. Study completion21 Mar 2024 (estimated)

Resources

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)
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

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.

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