Dipole Density Mapping of Typical Atrial Flutter

Not Applicable

Completed

• Conditions: Atrial Flutter
• Interventions: Device: Acutus Medical System Mapping

• Registration Number: NCT01914497
• Lead Sponsor: Acutus Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Study Start: 2014-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acutus Medical System	Acutus Medical System Mapping	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.

Primary Outcome Measures

Name	Time	Method
Incidence of device-and procedure-related adverse events	7 days
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed	7 days

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany