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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiology catheters and cables | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Signal quality | Good signal amplitude and signal stability throughout the procedure without artefact | Through study completion, an average of 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Micro-stimulation | Micro-stimulation worked well. | Through study completion, an average of 4 hours |
| Manoeuvrability | Ease of positioning and manoeuvrability the catheter (access to the desired area) |
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Inclusion Criteria:
To be included, patients must be:
Exclusion Criteria:
A patient will not be eligible to participate in the study if any of the following conditions are present:
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Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac arrythmias).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Rhône Durance | Avignon | 84000 | France | |||
| Hôpital Henri-Mondor AP-HP |
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| Through study completion, an average of 4 hours |
| Bending | Link between the wheel and the bending for dynamic Xtrem and bending stability | Through study completion, an average of 4 hours |
| Imaging | Visibility via X ray or 3D navigation. | Through study completion, an average of 4 hours |
| Diagnosis | Diagnosis efficiency | Through study completion, an average of 4 hours |
| Créteil |
| Île-de-France Region |
| 94000 |
| France |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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