Continuous 7-day Detection of Arrhythmias in Dialysis Population

NCT ID: NCT04071054

Last Updated: 2019-08-28

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-12-31

Brief Summary

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The Carnation Ambulatory Monitor (CAM) is an innovative diagnostic patch device that allows to differentiate the different kinds of arrhythmias more precisely than any other ECG-monitoring device. It attaches on the sternum and can be carried for a week without any breaks. This allows a continuous rhythm monitoring without any gap for 7 days.

This device will be used in dialysis patients to monitor arrhythmias during changes in volume and/or electrolyte balance due to dialysis, in the phases after dialysis as well as before dialysis in the short or long intervals between dialysis sessions.

Detailed Description

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Conditions

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Arrythmia Dialysis; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodialysis patients

Carnation Ambulatory Monitor (CAM)

Intervention Type DIAGNOSTIC_TEST

7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)

Interventions

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Carnation Ambulatory Monitor (CAM)

7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 years.
* Written informed consent

Exclusion Criteria

* Participation in another study within 4 weeks before study begin
* Pacemaker
* ICD
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Guerkan SENGOELGE

Optimized continuous 7-day detection of arrhythmias in dialysis population by a patch with a high resolution differentiation of atrial activity

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gürkan Sengölge, Prof.

Role: CONTACT

+4314040043910

Facility Contacts

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Guerkan Sengoelge

Role: primary

+4314040043890

Other Identifiers

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Continuous 7-day ECG

Identifier Type: -

Identifier Source: org_study_id

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