Status:
COMPLETED
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus 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
- Age 18-75 years
- One documented occurrence of typical AFL within the past 6 months
- Be able and willing to sign informed consent
Exclusion
- Contraindication to a non-emergent interventional EP procedure
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01872052
Start Date
March 1 2013
End Date
August 1 2014
Last Update
March 7 2017
Active Locations (1)
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1
AZ Sint-Jan
Bruges, Belgium, 8000