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

N/ACompletedNCT01872052

Acutus Medical9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atrial Flutter

Interventions

Acutus Medical System MappingDEVICE

Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

AZ Sint-Jan

Bruges, Belgium

Outcomes

Primary Outcomes

The number of patients in which offline construction of pre- and post-treatment activation maps can be completed

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.

Time frame: 3 months post-procedure

The number of patients that experience a device-related adverse events as a measure of safety and tolerability

Time frame: 7 days post-procedure

Data from ClinicalTrials.gov

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