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The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation procedure | Other | Collect intra-cardiac signals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation procedure | Procedure | The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intra-cardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-procedural investigational device success | Intra-procedural investigational device success
Measured by number and percentage of physicians able to deploy and collect intra-cardiac signals as outlined in the protocol | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the ideal workflow | Characterize the ideal workflow (defined as catheter preparation, connectivity, and configuration) and the use of the Picasso NAV Catheter's ability to map areas of interest Measured by survey questions | Intra-procedure |
| Visualize the device |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this clinical investigation.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not eligible for enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Tom De Potter | OLV Hospital | Principal Investigator |
| Petr Neuzil | Na Homolce Hospital | Principal Investigator |
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| 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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|
| Picasso NAV Catheter | Device |
|
Ability to visualize the device Measured by survey questions |
| Up to 3 months |
| Overall safety | Overall safety
Measured by number and percentage of patients experiencing those adverse events | Up to 7 days |