Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
DDRAMATIC
1 other identifier
interventional
9
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 Mar 2013
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
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMarch 7, 2017
March 1, 2017
1.3 years
May 2, 2013
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
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.
3 months post-procedure
The number of patients that experience a device-related adverse events as a measure of safety and tolerability
7 days post-procedure
Study Arms (1)
Acutus Medical System
EXPERIMENTALInterventions
Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
Eligibility Criteria
You may qualify if:
- Age 18-75 years
- One documented occurrence of typical AFL within the past 6 months
- Be able and willing to sign informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acutus Medicallead
Study Sites (1)
AZ Sint-Jan
Bruges, 8000, Belgium
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
May 2, 2013
First Posted
June 7, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
March 7, 2017
Record last verified: 2017-03