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NCT02469636 Clinical Trial

Dipole Density Mapping in Supraventricular Tachycardia

Supraventricular Tachycardia Clinical Trial

— DDRAMATIC-SVT  

Official title:
Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02469636
Other study ID # CL-SVT-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2014
Est. completion date May 22, 2017

Study information
Verified date January 2019
Source Acutus Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of dipole density mapping to identify activation in complex supraventricular tachycardias

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date May 22, 2017
Est. primary completion date May 22, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation

2. 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dipole Density Mapping with AcQMap followed by ablation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Acutus Medical

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of device-and procedure-related adverse events 7 days
Primary The number of patients for which activation maps can be created 1 day
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