Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter (DDRAMATIC)
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Acutus Medical System Mapping
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Flutter
Eligibility 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
Sites / Locations
- AZ Sint-Jan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acutus Medical System
Arm Description
Outcomes
Primary Outcome Measures
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.
The number of patients that experience a device-related adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01872052
Brief Title
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Acronym
DDRAMATIC
Official Title
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acutus Medical
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acutus Medical System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Acutus Medical System Mapping
Intervention Description
Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
Primary Outcome Measure Information:
Title
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
Description
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.
Time Frame
3 months post-procedure
Title
The number of patients that experience a device-related adverse events as a measure of safety and tolerability
Time Frame
7 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
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