Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia

NCT ID: NCT01914575

Last Updated: 2019-01-31

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-22

Study Completion Date

2016-05-16

Brief Summary

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Use of dipole density mapping to identify activation in complex supraventricular tachycardias

Detailed Description

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Conditions

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Supraventricular Tachycardia

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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Dipole Density Mapping

Group Type EXPERIMENTAL

Mapping with the Acutus Medical System followed by Ablation

Intervention Type DEVICE

Interventions

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Mapping with the Acutus Medical System followed by Ablation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. aged 18 to 75 years
2. scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation
3. able and willing to give informed consent

Exclusion Criteria

1. implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation .
2. myocardial infarction within the prior two months
3. cardiac surgery within the prior three months
4. intracardiac thrombus
5. clinically significant tricuspid valve regurgitation or stenosis
6. any cerebral ischemic event in the prior six months
7. pregnant or nursing
8. currently enrolled in any other clinical investigation
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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David Keane, MD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's University Hospital

Locations

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St. Vincent's University Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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CL-SVT-003

Identifier Type: -

Identifier Source: org_study_id

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