NCT05314218
Completed
Not Applicable
EPICADIA - Electrophysiologic Performance Investigation for CArdiac DIAgnosis
ConditionsCardiac Arrhythmia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Alcis
- Enrollment
- 168
- Locations
- 2
- Primary Endpoint
- Signal quality
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Signal quality
Time Frame: Through study completion, an average of 4 hours
Good signal amplitude and signal stability throughout the procedure without artefact
Secondary Outcomes
- Imaging(Through study completion, an average of 4 hours)
- Micro-stimulation(Through study completion, an average of 4 hours)
- Bending(Through study completion, an average of 4 hours)
- Diagnosis(Through study completion, an average of 4 hours)
- Manoeuvrability(Through study completion, an average of 4 hours)
Study Sites (2)
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