Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter (DDRAMATIC)

Acutus Medical

Status: Completed

Conditions: Atrial Flutter

Treatments: Device: Acutus Medical System Mapping

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872052

CL-AFL-001

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 years
• One documented occurrence of typical AFL within the past 6 months
• Be able and willing to sign informed consent

Exclusion criteria

• Contraindication to a non-emergent interventional EP procedure
• Require treatment in or access to left atrium
• Had a myocardial infarction within the prior two months
• Had cardiac surgery within the prior three months
• Intracardiac thrombus
• Permanent pacemaker/ICD leads in/through right atrium
• Clinically significant tricuspid valve regurgitation or stenosis
• Cerebral ischemic event (including TIA) in the prior six months
• Pregnant
• Currently enrolled in any other clinical investigation
• Any other significant uncontrolled or unstable medical condition

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Acutus Medical System

Experimental group

Treatment:

Device: Acutus Medical System Mapping