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

NCT ID: NCT01872052

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Atrial Flutter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acutus Medical System

Group Type EXPERIMENTAL

Acutus Medical System Mapping

Intervention Type DEVICE

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

Interventions

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Acutus Medical System Mapping

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acutus Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Willems, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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AZ Sint-Jan

Bruges, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CL-AFL-001

Identifier Type: -

Identifier Source: org_study_id

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