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Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia (DDRAMATIC-SVT)

Primary Purpose

Supraventricular Tachycardia

Status
Withdrawn
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Mapping with the Acutus Medical System followed by Ablation
Sponsored by
Acutus Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Supraventricular Tachycardia

Eligibility Criteria

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

Inclusion Criteria:

  1. aged 18 to 75 years
  2. scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
  3. able and willing to give informed consent

Exclusion Criteria:

  1. implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
  2. myocardial infarction within the prior two months
  3. cardiac surgery within the prior three months
  4. intracardiac thrombus
  5. clinically significant tricuspid valve regurgitation or stenosis
  6. any cerebral ischemic event in the prior six months
  7. pregnant or nursing
  8. currently enrolled in any other clinical investigation

Sites / Locations

  • St. Vincent's University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dipole Density Mapping

Arm Description

Outcomes

Primary Outcome Measures

The number of patients with device-related complications
The number of patients for which activation maps can be created

Secondary Outcome Measures

Full Information

First Posted
July 31, 2013
Last Updated
January 29, 2019
Sponsor
Acutus Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01914575
Brief Title
Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia
Acronym
DDRAMATIC-SVT
Official Title
Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Site never got up and running due to institutional issues
Study Start Date
January 22, 2014 (Anticipated)
Primary Completion Date
May 16, 2016 (Actual)
Study Completion Date
May 16, 2016 (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
Use of dipole density mapping to identify activation in complex supraventricular tachycardias

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dipole Density Mapping
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mapping with the Acutus Medical System followed by Ablation
Primary Outcome Measure Information:
Title
The number of patients with device-related complications
Time Frame
7 days
Title
The number of patients for which activation maps can be created
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: aged 18 to 75 years scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation able and willing to give informed consent Exclusion Criteria: implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation . myocardial infarction within the prior two months cardiac surgery within the prior three months intracardiac thrombus clinically significant tricuspid valve regurgitation or stenosis any cerebral ischemic event in the prior six months pregnant or nursing currently enrolled in any other clinical investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Keane, MD
Organizational Affiliation
St. Vincent's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia

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