Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2014-10-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Acutus Medical System
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.
Acutus Medical System Mapping
Interventions
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Acutus Medical System Mapping
Eligibility Criteria
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Inclusion Criteria
2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
3. Be able and willing to give informed consent
Exclusion Criteria
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.
2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
3. Have had a myocardial infarction within the prior two months
4. Have had cardiac surgery within the prior three months
5. Have an intracardiac thrombus
6. Have clinically significant tricuspid valve regurgitation or stenosis
7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
8. Be pregnant or nursing
9. Be currently enrolled in any other clinical investigation
18 Years
75 Years
ALL
No
Sponsors
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Acutus Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Willems, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Countries
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Other Identifiers
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CL-AFL-002
Identifier Type: -
Identifier Source: org_study_id