Status:
COMPLETED
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
Lead Sponsor:
Alcis
Conditions:
Cardiac Arrhythmia
Eligibility:
All Genders
18-90 years
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 demonstra...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05314218
Start Date
May 23 2022
End Date
May 26 2023
Last Update
June 13 2023
Active Locations (2)
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1
Clinique Rhône Durance
Avignon, France, 84000
2
Hôpital Henri-Mondor AP-HP
Créteil, Île-de-France Region, France, 94000