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Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acutus Medical System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acutus Medical System Mapping | Device | Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients in which offline construction of pre- and post-treatment activation maps can be completed | Proprietary software algorithms will be used generate electrical activation maps based dipole density data acquired by the Acutus Medical Catheter during the procedures. These activation maps will then be applied to a 3D model of the endocardial surface to create a 3D activation map. | 3 months post-procedure |
| The number of patients that experience a device-related adverse events as a measure of safety and tolerability | 7 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Willems, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan | Bruges | 8000 | Belgium |
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |