Continuous 7-day Detection of Arrhythmias in Dialysis Population

Arrythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071054
• Other study ID #: Continuous 7-day ECG
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Medical University of Vienna
• Contact: Gürkan Sengölge, Prof.
• Phone: +4314040043910
• Email: guerkan.sengoelge[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age 18 years.

• Written informed consent

Exclusion Criteria:

• Participation in another study within 4 weeks before study begin

• Pacemaker

• ICD

Related Conditions & MeSH terms

• Arrythmia
• Dialysis; Complications

Intervention

Diagnostic Test:
• Carnation Ambulatory Monitor (CAM)
7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)

Locations

Country	Name	City	State
Austria	Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dialysis patients with an arrhythmia	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)