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
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
1. Be aged 18 to 75 years 2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent) 3. Be able and willing to give informed consent
Exclusion criteria
1. 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. 2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure 3. Have had a myocardial infarction within the prior two months 4. Have had cardiac surgery within the prior three months 5. Have an intracardiac thrombus 6. Have clinically significant tricuspid valve regurgitation or stenosis 7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months 8. Be pregnant or nursing 9. Be currently enrolled in any other clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device-and procedure-related adverse events | 7 days |
| The number of patients in which offline construction of pre- and post-treatment activation maps can be completed | 7 days |
Countries
Germany
Outcome results
None listed