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

Completed

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT05314218
• Lead Sponsor: Alcis

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Start: 2022-05-23
• Primary Completion: 2023-05-25
• Study Completion: 2023-05-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Signal quality	Through study completion, an average of 4 hours	Good signal amplitude and signal stability throughout the procedure without artefact

Secondary Outcome Measures

Name	Time	Method
Imaging	Through study completion, an average of 4 hours	Visibility via X ray or 3D navigation.
Micro-stimulation	Through study completion, an average of 4 hours	Micro-stimulation worked well.
Bending	Through study completion, an average of 4 hours	Link between the wheel and the bending for dynamic Xtrem and bending stability
Diagnosis	Through study completion, an average of 4 hours	Diagnosis efficiency
Manoeuvrability	Through study completion, an average of 4 hours	Ease of positioning and manoeuvrability the catheter (access to the desired area)

Trial Locations

Locations (2)

Hôpital Henri-Mondor AP-HP; 🇫🇷 Créteil, Ile De France, France

Clinique Rhône Durance; 🇫🇷 Avignon, France