Continuous 7-day Detection of Arrhythmias in Dialysis Population

August 26, 2019 updated by: Guerkan SENGOELGE, Medical University of Vienna

Optimized Continuous 7-day Detection of Arrhythmias in Dialysis Population by a Patch With a High Resolution Differentiation of Atrial Activity

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1180
        • Recruiting
        • Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
        • Contact:
          • Guerkan Sengoelge
          • Phone Number: +4314040043890

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hemodialysis patients with a chronic hemodialysis program

Description

Inclusion Criteria:

  • Age 18 years.
  • Written informed consent

Exclusion Criteria:

  • Participation in another study within 4 weeks before study begin
  • Pacemaker
  • ICD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodialysis patients
Diagnostic test: Carnation Ambulatory Monitor (CAM)
7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of dialysis patients with an arrhythmia
Time Frame: ECG monitoring over 7 days (3 intermittent hemodialysis sessions)
Detection of arrhythmias (including distribution of ventricular and atrial arrhythmias) by means of Carnation Ambulatory Monitor (CAM) in hemodialysis patients during an entire week, thus including all different phases: during/after/before dialysis sessions
ECG monitoring over 7 days (3 intermittent hemodialysis sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 24, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Continuous 7-day ECG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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