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

Not Applicable

Completed

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

• Registration Number: NCT01872052
• 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 Start: 2013-03
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acutus Medical System	Acutus Medical System Mapping	-

Primary Outcome Measures

Name	Time	Method
The number of patients in which offline construction of pre- and post-treatment activation maps can be completed	3 months post-procedure	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.
The number of patients that experience a device-related adverse events as a measure of safety and tolerability	7 days post-procedure

Trial Locations

Locations (1)

AZ Sint-Jan; 🇧🇪 Brugge, Belgium