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.
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 Type
OBSERVATIONAL
Enrollment
168
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.
Clinique Rhône Durance
Avignon, France
Hôpital Henri-Mondor AP-HP
Créteil, Île-de-France Region, France
Signal quality
Good signal amplitude and signal stability throughout the procedure without artefact
Time frame: Through study completion, an average of 4 hours
Micro-stimulation
Micro-stimulation worked well.
Time frame: Through study completion, an average of 4 hours
Manoeuvrability
Ease of positioning and manoeuvrability the catheter (access to the desired area)
Time frame: Through study completion, an average of 4 hours
Bending
Link between the wheel and the bending for dynamic Xtrem and bending stability
Time frame: Through study completion, an average of 4 hours
Imaging
Visibility via X ray or 3D navigation.
Time frame: Through study completion, an average of 4 hours
Diagnosis
Diagnosis efficiency
Time frame: Through study completion, an average of 4 hours
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