Atrial Flutter
Conditions
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.
Interventions
Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
Sponsors
Acutus Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * One documented occurrence of typical AFL within the past 6 months * Be able and willing to sign informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients in which offline construction of pre- and post-treatment activation maps can be completed | 3 months post-procedure | 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. |
| The number of patients that experience a device-related adverse events as a measure of safety and tolerability | 7 days post-procedure | — |
Countries
Belgium
Outcome results
None listed