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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05765565
Other study ID # MEC-2022-0269
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 21, 2023
Est. completion date March 21, 2024

Study information

Verified date March 2023
Source Erasmus Medical Center
Contact Bakhtawar Mahmoodi, MD PhD MPH
Phone +31611828388
Email b.mahmoodi@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date March 21, 2024
Est. primary completion date March 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - Individuals not able to provide informed consent for any reason including language and mental disabilities

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Octaray multi-electrode catheter
Newly designed multi-electrode catheter for creating 3D electroanatomical CARTO maps.
Pentaray multi-electrode catheter
Current standard multi-electrode catheter for creating 3D electroanatomical CARTO maps.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Number of electrograms per map during procedure
Secondary Voltage based signal-to-noise ratio. during procedure
Secondary electrograms acquisition rate the acquired number of points per minute of mapping) during procedure
Secondary electrogram acquisition density the acquired number of electrograms per cm2 of the left or right atrium during procedure
Secondary number of electrograms acquired per beat during procedure
Secondary the total ablation and fluoroscopy times during procedure
Secondary acute mapping success rate defined as termination of AT at the target region during procedure
Secondary number of entrainments attempted and the best post-pacing interval value at the ablation site May not be available especially in focal AT's during procedure
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