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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
Acutus Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Flutter

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 2, 2013
Last Updated
March 6, 2017
Sponsor
Acutus Medical
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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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