Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia

NCT01914575 — Not applicable, Withdrawn, Acutus Medical

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

Registry	NCT01914575, acronym DDRAMATIC-SVT
Status	Withdrawn - Site never got up and running due to institutional issues
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Sponsor	Acutus Medical (Industry)
Conditions	Supraventricular Tachycardia
Interventions	Mapping with the Acutus Medical System followed by Ablation (Device)
Dates	start 2014-01-22 (estimated), primary completion 2016-05-16, completion 2016-05-16, first posted 2013-08-02, last updated 2019-01-31
Locations	1 site in Ireland

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Dipole Density Mapping	Experimental	Device: Mapping with the Acutus Medical System followed by Ablation

Mapping with the Acutus Medical System followed by Ablation (Device)

+Outcome measures

Primary outcomes

The number of patients with device-related complications [7 days]
The number of patients for which activation maps can be created [7 days]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
St. Vincent's University Hospital	Dublin	Ireland

+Investigators

David Keane, MD, Principal investigator, St Vincent's University Hospital, Ireland