Comparison Between the Octaray and Pentaray Catheters in Patients Undergoing Ablation for Atrial Tachycardia. (OCTOPUS-AT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Tachycardia
• Intervention / Treatment: Device: Octaray multi-electrode catheter; Device: Pentaray multi-electrode catheter

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bakhtawar Mahmoodi, MD PhD MPH; Phone Number: +31611828388; Email: b.mahmoodi@erasmusmc.nl
• Study Contact Backup: Name: Tamas Szili-Torok, MD PhD; Email: t.szilitorok@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Octaray (intervention); Octaray created 3D map quality	Device: Octaray multi-electrode catheter; Newly designed multi-electrode catheter for creating 3D electroanatomical CARTO maps.
Active Comparator: Pentaray (control); Pentaray created 3D map quality	Device: Pentaray multi-electrode catheter; Current standard multi-electrode catheter for creating 3D electroanatomical CARTO maps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of electrograms per map	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voltage based signal-to-noise ratio.		during procedure
electrograms acquisition rate	the acquired number of points per minute of mapping)	during procedure
electrogram acquisition density	the acquired number of electrograms per cm2 of the left or right atrium	during procedure
number of electrograms acquired per beat		during procedure
the total ablation and fluoroscopy times		during procedure
acute mapping success rate	defined as termination of AT at the target region	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	during procedure

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 21, 2023
• Primary Completion (Anticipated): March 21, 2024
• Study Completion (Anticipated): March 21, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: MEC-2022-0269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Needs to be discussed with the catheter manufacturer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No