NCT05765565

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2024

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 1, 2023

Last Update Submit

March 1, 2023

Conditions

Atrial Tachycardia

Outcome Measures

Primary Outcomes (1)

  • Number of electrograms per map

    during procedure

Secondary Outcomes (7)

  • Voltage based signal-to-noise ratio.

    during procedure

  • electrograms acquisition rate

    during procedure

  • electrogram acquisition density

    during procedure

  • number of electrograms acquired per beat

    during procedure

  • the total ablation and fluoroscopy times

    during procedure

  • +2 more secondary outcomes

Study Arms (2)

Octaray (intervention)

EXPERIMENTAL

Octaray created 3D map quality

Device: Octaray multi-electrode catheter

Pentaray (control)

ACTIVE COMPARATOR

Pentaray created 3D map quality

Device: Pentaray multi-electrode catheter

Interventions

Octaray multi-electrode catheterDEVICE

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

Octaray (intervention)
Pentaray multi-electrode catheterDEVICE

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

Pentaray (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Bakhtawar Mahmoodi, MD PhD MPH

CONTACT

+31611828388b.mahmoodi@erasmusmc.nl

Tamas Szili-Torok, MD PhD

CONTACT

t.szilitorok@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

March 21, 2023

Primary Completion

March 21, 2024

Study Completion

March 21, 2024

Last Updated

March 13, 2023

Record last verified: 2023-03