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Dipole Density Mapping of Typical Atrial Flutter (DDRAMATIC)

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
Germany
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:

  1. Be aged 18 to 75 years
  2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
  3. Be able and willing to give informed consent

Exclusion Criteria:

  1. Have any of the following:

    1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.

    1.2 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.

  2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
  3. Have had a myocardial infarction within the prior two months
  4. Have had cardiac surgery within the prior three months
  5. Have an intracardiac thrombus
  6. Have clinically significant tricuspid valve regurgitation or stenosis
  7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
  8. Be pregnant or nursing
  9. Be currently enrolled in any other clinical investigation

Sites / Locations

  • Universitätsklinikum Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acutus Medical System

Arm 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.

Outcomes

Primary Outcome Measures

Incidence of device-and procedure-related adverse events
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed

Secondary Outcome Measures

Full Information

First Posted
July 31, 2013
Last Updated
November 29, 2017
Sponsor
Acutus Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01914497
Brief Title
Dipole Density Mapping of Typical Atrial 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
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acutus Medical

4. Oversight

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
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acutus Medical System
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Acutus Medical System Mapping
Primary Outcome Measure Information:
Title
Incidence of device-and procedure-related adverse events
Time Frame
7 days
Title
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
Time Frame
7 days

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: 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 Exclusion Criteria: Have any of the following: 1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped. 1.2 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
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
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany

12. IPD Sharing Statement

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Dipole Density Mapping of Typical Atrial Flutter

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