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OpenTrials
Completed

NCT Number: NCT05314218

The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting

The objective of this multicentre study is to collect operative data on the related clinical functional outcomes and complications and of market approved Alcis electrophysiology catheters to demonstrate safety and performance of these devices in a real-world setting.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Henri-Mondor AP-HP, Créteil, Île-de-France Region, France

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About this study

Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis devices and support peer-reviewed publications on products performance and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be included, patients must be:

  • 18 to 90 years old
  • Patient who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias)
  • Informed and willing to sign an informed consent for approved by EC
  • Affiliation to the social security or foreign regime recognized in France

Exclusion criteria

A patient will not be eligible to participate in the study if any of the following conditions are present:

  • Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).
  • Any medical condition that could impact the study at investigator's discretion (e.g. allergy…).
  • Pregnant women
  • Adult subject to legal protection measure

Treatment and study plan

Electrophysiology catheters and cables

Device

The Xtrem electrophysiology catheter was developed for diagnosis of cardiac arrhythmias. Their function is to collect by contact, electrical signals generated by the heart muscle.

Xtrem are inserted via femoral vena cava or via artery and can be used in two occasions:

  • Exploration procedures for diagnosis alone
  • Diagnosis before ablation procedure An extension cable is used to connect the catheter to a stimulation/ recording device.

Primary outcomes

  1. Signal quality

    Time frame: Through study completion, an average of 4 hours

    Good signal amplitude and signal stability throughout the procedure without artefact

Secondary outcomes

  1. Micro-stimulation

    Time frame: Through study completion, an average of 4 hours

    Micro-stimulation worked well.

  2. Manoeuvrability

    Time frame: Through study completion, an average of 4 hours

    Ease of positioning and manoeuvrability the catheter (access to the desired area)

  3. Bending

    Time frame: Through study completion, an average of 4 hours

    Link between the wheel and the bending for dynamic Xtrem and bending stability

  4. Imaging

    Time frame: Through study completion, an average of 4 hours

    Visibility via X ray or 3D navigation.

  5. Diagnosis

    Time frame: Through study completion, an average of 4 hours

    Diagnosis efficiency

Sponsors and collaborators

Lead sponsor

Alcis

Industry

Registry information

Official study title

EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2022
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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