Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
NCT ID: NCT01872052
Last Updated: 2017-03-07
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
9 participants
INTERVENTIONAL
2013-03-31
2014-08-31
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
Acutus Medical System Mapping
Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
Interventions
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Acutus Medical System Mapping
Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
Eligibility Criteria
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Inclusion Criteria
* One documented occurrence of typical AFL within the past 6 months
* Be able and willing to sign informed consent
Exclusion Criteria
* Require treatment in or access to left atrium
* Had a myocardial infarction within the prior two months
* Had cardiac surgery within the prior three months
* Intracardiac thrombus
* Permanent pacemaker/ICD leads in/through right atrium
* Clinically significant tricuspid valve regurgitation or stenosis
* Cerebral ischemic event (including TIA) in the prior six months
* Pregnant
* Currently enrolled in any other clinical investigation
* Any other significant uncontrolled or unstable medical condition
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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AZ Sint-Jan
Bruges, , Belgium
Countries
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Other Identifiers
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CL-AFL-001
Identifier Type: -
Identifier Source: org_study_id
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