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

EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Alcis · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-23
• Primary completion: 2023-05-25
• Completion: 2023-05-26
• First posted: 2022-04-06
• Last updated: 2023-06-13

Locations

2 sites across 1 country: France