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Not yet recruiting NCT07353710

A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure

No phase Interventional Atrial Arrhythmia Intracardiac Echocardiography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICE Image Acquisition.
Who it may be relevant to
Registry conditions: Atrial Arrhythmia, Intracardiac Echocardiography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Croatia, Czechia, Greece, Malaysia +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.

Interventions

  • Device ICE Image Acquisition
    ICE image acquisition using the investigational device

Primary outcome measures

  • The incidence of procedure related serious adverse events and all adverse events [Time frame: 7 Days]

Eligibility criteria

Inclusion criteria

  • Subjects who are able and willing to provide written informed consent prior to any study procedure.
  • Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice.
  • Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation center.
  • Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion criteria

  • Any of the following cardiac implanted devices
  • Any prosthetic mitral or tricuspid heart valve, such as ring, repairs or clips
  • Atrial septal defect (ASD) occluders including interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder
  • Subjects with contraindications related to the use of the CHORUS IDx™ System:
  • Subjects with inadequate vascular access
  • Subjects with active systemic infection
  • Subjects with presence of a known intracardiac thrombus in the chamber of use
  • Women who are confirmed to be pregnant or lactating at the time of the Index Procedure
  • Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study
  • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Australia · 1 center
  • Lingard Private Hospital — Merewether
Croatia · 1 center
  • Klinicki Bolnicki Centar Split — Split
Czechia · 1 center
  • IKEM - Institut klinicke a experimentalni mediciny — Prague
Greece · 1 center
  • Hygeia Hospital — Athens
Malaysia · 1 center
  • Institut Jantung Negara — Kuala Lumpur
New Zealand · 1 center
  • Auckland City Hospital — Auckland
Poland · 1 center
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego — Warsaw
Singapore · 1 center
  • National Heart Center Singapore — Singapore

Identifiers

NCT: NCT07353710 · PF339

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗