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| Name | Class |
|---|---|
| TRIQ GROUP Wherry & Klaffke GbR | UNKNOWN |
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The primary objective is to evaluate the safety and technical performance of the CathVision CubeĀ® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.
A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision CubeĀ® system.
Patients undergoing assessment and ablation of cardiac arrhythmias, by Electro Physiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision CubeĀ® System in parallel with a commercial (CE marked) EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A prospective, multi-center, open-label, single arm study | Other | Patients undergoing assessment and ablation of cardiac arrhythmiast. who are scheduled for an electrophysiology (EP) procedure and meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision CubeĀ® System in parallel with the commercial (CE marked) EP recording system for post procedure evaluation. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP Procedure | Procedure | Intracardiac signals will be passively recorded using CathVision CubeĀ® System in parallel with the commercial (CE marked) EP recording system during a scheduled electrophysiology procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major adverse events, evaluated at hospital discharge. | Freedom from major adverse events, evaluated at hospital discharge | From EP procedure to hospital discharge is 1 day |
| Recording low-voltage electrograms | Recording low-voltage electrograms under 20uV amplitude | Duration of the EP procedure can take up to 6 hours |
| The Primary Performance endpoint of study will be evaluated as technical success of CathVision CubeĀ® system to collect and record intracardiac signals during EP procedures | Logging time for arrhythmia termination / block | Duration of the EP procedure can take up to 6 hours |
| Compatibility of Cube System with commercially available 3D mapping system | Assessing compatibility of Cube System with commercially available 3D mapping system with available intracardiac catheters. Compatibility is assessed by that the Cube System does not introduce a visual detectable distortion on the commercial available 3D mapping systems | Duration of the EP procedure can take up to 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josef Kautzner, Prof. | IKEM, Prague, Czech Republic | Principal Investigator |
| Peter K Jacobsen, MD, DMSc | Righospitalet, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IKEM, Institue of Clinical and Experimental Medicine | Prague | 14021 Praha 4 | Czechia | |||
| Rigshospitalet |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision CubeĀ® system.
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| Copenhagen |
| 2100 |
| Denmark |