Continuous 7-day Detection of Arrhythmias in Dialysis Population
Optimized Continuous 7-day Detection of Arrhythmias in Dialysis Population by a Patch With a High Resolution Differentiation of Atrial Activity
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 24, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 28, 2019
August 1, 2019
1.4 years
August 24, 2019
August 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Hemodialysis patients
Interventions
7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)
Eligibility Criteria
Hemodialysis patients with a chronic hemodialysis program
You may qualify if:
- Age 18 years.
- Written informed consent
You may not qualify if:
- Participation in another study within 4 weeks before study begin
- Pacemaker
- ICD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
Vienna, 1180, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Optimized continuous 7-day detection of arrhythmias in dialysis population by a patch with a high resolution differentiation of atrial activity
Study Record Dates
First Submitted
August 24, 2019
First Posted
August 28, 2019
Study Start
August 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
August 28, 2019
Record last verified: 2019-08