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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

NCT05314218 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2023-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Arrhythmia

Interventions

DEVICE

Electrophysiology catheters and cables

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.

Sponsors & Collaborators

  • Alcis

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2023-05-25
Completion
2023-05-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05314218 on ClinicalTrials.gov