Developing Methods for Reconstructing Electrical Heart Activity

NCT ID: NCT03947021

Last Updated: 2021-09-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2022-03-31

Brief Summary

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Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.

Detailed Description

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Conditions

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Heart Diseases Cardiac Conduction Defect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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BSPM-only group

Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).

Group Type EXPERIMENTAL

Body-surface potential mapping

Intervention Type DEVICE

Measurement of 256-lead body-surface electrocardiogram

CT+BSPM group

Participants will receive body-surface potential measurements (BSPM) and a CT scan. These data will allow for non-invasive reconstruction of electrical potentials at the heart surface.

Group Type EXPERIMENTAL

Computed tomography (CT) scan

Intervention Type RADIATION

A CT scan of thorax and heart will be performed in the CT+BSPM group.

Body-surface potential mapping

Intervention Type DEVICE

Measurement of 256-lead body-surface electrocardiogram

Interventions

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Computed tomography (CT) scan

A CT scan of thorax and heart will be performed in the CT+BSPM group.

Intervention Type RADIATION

Body-surface potential mapping

Measurement of 256-lead body-surface electrocardiogram

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* able to provide informed consent
* Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC), demonstrated ventricular arrhythmias (resuscitation, (non)sustained ventricular tachycardia, ventricular fibrillation)
* Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator


\- Existing medical indication for a cardiac CT scan unrelated to this research

Exclusion Criteria

\- Known strong reaction against electrode attachment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NHS 2007T51

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

METC 11-2-043

Identifier Type: -

Identifier Source: org_study_id

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