Dipole Density Mapping of Typical Atrial Flutter (DDRAMATIC)

Acutus Medical

Status: Completed

Conditions: Atrial Flutter

Treatments: Device: Acutus Medical System Mapping

Study type: Interventional

Funder types: Industry

Identifiers

NCT01914497

CL-AFL-002

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: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be aged 18 to 75 years
2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
3. Be able and willing to give informed consent

Exclusion criteria

1. Have any of the following:

   1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.

   1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.

2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure

3. Have had a myocardial infarction within the prior two months

4. Have had cardiac surgery within the prior three months

5. Have an intracardiac thrombus

6. Have clinically significant tricuspid valve regurgitation or stenosis

7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months

8. Be pregnant or nursing

9. Be currently enrolled in any other clinical investigation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Acutus Medical System

Experimental group

Description:

Proprietary software algorithms will be used generate electrical activation maps based dipole density data acquired by the Acutus Medical Catheter during the procedures. These activation maps will then be applied to a 3D model of the endocardial surface to create a 3D activation map.

Treatment:

Device: Acutus Medical System Mapping