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NCT01914549 Clinical Trial

Dipole Density Mapping of 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 NCT01914549
Other study ID # CL-SVT-001
Secondary ID
Status Completed
Phase N/A
First received July 31, 2013
Last updated March 6, 2017
Start date April 2015
Est. completion date April 2016

Study information
Verified date March 2017
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 2
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mapping with the Acutus Medical System followed by Ablation

Locations
Country Name City State
Belgium AZ Sint-Jan Brugge

Sponsors (1)
Lead Sponsor Collaborator
Acutus Medical

Country where clinical trial is conducted

Belgium, 

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 7 days
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