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OpenTrials
Completed

NCT Number: NCT01914497

Dipole Density Mapping of Typical Atrial Flutter

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.

Completed

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acutus Medical System Mapping

Device

Primary outcomes

  1. Incidence of device-and procedure-related adverse events

    Time frame: 7 days

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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Acutus Medical

Industry

Registry information

Official study title

Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter

Acronym: DDRAMATIC

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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