Dipole Density Mapping of Typical Atrial Flutter
DDRAMATIC
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 2, 2017
November 1, 2017
1 month
July 31, 2013
November 29, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Acutus Medical System
EXPERIMENTALProprietary 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have any of the following:
- Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acutus Medicallead
Study Sites (1)
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Willems, MD
Universitätsklinikum Hamburg-Eppendorf
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 2, 2013
Study Start
October 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 2, 2017
Record last verified: 2017-11