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

Alcis

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Device: Electrophysiology catheters and cables

Study type: Observational

Funder types: Industry

Identifiers

NCT05314218

2045-CIP_v1_01Feb2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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