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

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ClinicalTrials.gov Identifier: NCT01872052
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Acutus Medical

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.

Condition or disease Intervention/treatment Phase
Atrial Flutter Device: Acutus Medical System Mapping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Acutus Medical System Device: Acutus Medical System Mapping
Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter




Primary Outcome Measures :
  1. The number of patients in which offline construction of pre- and post-treatment activation maps can be completed [ Time Frame: 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.

  2. The number of patients that experience a device-related adverse events as a measure of safety and tolerability [ Time Frame: 7 days post-procedure ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872052


Locations
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Belgium
AZ Sint-Jan
Brugge, Belgium, 8000
Sponsors and Collaborators
Acutus Medical
Investigators
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Principal Investigator: Stephan Willems, MD Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Acutus Medical
ClinicalTrials.gov Identifier: NCT01872052     History of Changes
Other Study ID Numbers: CL-AFL-001
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes