ArrythmiaNCT04071054
Continuous 7-day Detection of Arrhythmias in Dialysis Population
An observational study of Arrythmia and Dialysis; Complications, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrythmia, Dialysis; Complications
- What is being tested?
- Carnation Ambulatory Monitor (CAM)
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hemodialysis patients with a chronic hemodialysis program
Who may be able to join
- Age 18 years.
- Written informed consent
Who cannot join
- Participation in another study within 4 weeks before study begin
- Pacemaker
- ICD
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
Vienna, 1180
Guerkan Sengoelge, +4314040043890
About this study
Official title: 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.
- Conditions
- Arrythmia, Dialysis; Complications
- Being tested
- Carnation Ambulatory Monitor (CAM)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carnation Ambulatory Monitor (CAM)Diagnostic test
7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Not described Receives: Diagnostic Test: Carnation Ambulatory Monitor (CAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ECG monitoring over 7 days (3 intermittent hemodialysis sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guerkan SENGOELGE, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071054
- Sponsor's protocol ID
- Continuous 7-day ECG
- Status last verified
- Aug 2019
- First submitted
- 24 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Continuous 7-day Detection of Arrhythmias in Dialysis Population by a Patch With a High Resolution Differentiation of Atrial Activity
- ClinicalTrials.gov ID
- NCT04071054
- Acronym / sponsor ID
- Continuous 7-day ECG
- Conditions
- Arrythmia, Dialysis; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Diagnostic Test: Carnation Ambulatory Monitor (CAM) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with a chronic hemodialysis program
Key inclusion criteria (2 listed)
- Age 18 years.
- Written informed consent
Key exclusion criteria (3 listed)
- Participation in another study within 4 weeks before study begin
- Pacemaker
- ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carnation Ambulatory Monitor (CAM)7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM) | Diagnostic test | Hemodialysis patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrythmia and Dialysis; Complications, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gürkan Sengölge, Prof. (+4314040043910, guerkan.sengoelge@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dialysis patients with an arrhythmia (time frame: ECG monitoring over 7 days (3 intermittent hemodialysis sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.