CompletedNot Applicable

Dipole Density Mapping of Typical Atrial Flutter

Germany3 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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 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

What they're measuring

Incidence of device-and procedure-related adverse events

Timeframe: 7 days

The number of patients in which offline construction of pre- and post-treatment activation maps can be completed

Timeframe: 7 days

Trial details

NCT IDNCT01914497

SponsorAcutus Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Atrial Flutter trials