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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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acutus Medical System Mapping | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device-and procedure-related adverse events | 7 days | |
| The number of patients in which offline construction of pre- and post-treatment activation maps can be completed | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
Have any of the following:
1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.
1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.
Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
Have had a myocardial infarction within the prior two months
Have had cardiac surgery within the prior three months
Have an intracardiac thrombus
Have clinically significant tricuspid valve regurgitation or stenosis
Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
Be pregnant or nursing
Be currently enrolled in any other clinical investigation
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Willems, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
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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 |