Status:
COMPLETED
Dipole Density Mapping of Typical Atrial Flutter
Lead Sponsor:
Acutus Medical
Conditions:
Atrial Flutter
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- Be aged 18 to 75 years
- Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
- Be able and willing to give informed consent
Exclusion
- Have any of the following:
- 1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01914497
Start Date
October 1 2014
End Date
November 1 2014
Last Update
December 2 2017
Active Locations (1)
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1
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany