Dipole Density Mapping of Typical Atrial Flutter (DDRAMATIC)
Atrial Flutter
About this trial
This is an interventional diagnostic trial for Atrial Flutter
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
- Universitätsklinikum Hamburg-Eppendorf
Arms of the Study
Arm 1
Experimental
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.