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

Cardiac Arrhythmia Clinical Trial

Official title:

EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314218
• Other study ID #: 2045-CIP_v1_01Feb2022
• Status: Completed
• Start date: May 23, 2022
• Est. completion date: May 26, 2023

Study information

• Verified date: June 2023
• Source: Alcis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 26, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Rhône Durance	Avignon
France	Hôpital Henri-Mondor AP-HP	Créteil	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Alcis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal quality	Good signal amplitude and signal stability throughout the procedure without artefact	Through study completion, an average of 4 hours
Secondary	Micro-stimulation	Micro-stimulation worked well.	Through study completion, an average of 4 hours
Secondary	Manoeuvrability	Ease of positioning and manoeuvrability the catheter (access to the desired area)	Through study completion, an average of 4 hours
Secondary	Bending	Link between the wheel and the bending for dynamic Xtrem and bending stability	Through study completion, an average of 4 hours
Secondary	Imaging	Visibility via X ray or 3D navigation.	Through study completion, an average of 4 hours
Secondary	Diagnosis	Diagnosis efficiency	Through study completion, an average of 4 hours