NCT05899959Completed
REmote CArdiac MOnitoring by the Corsano CardioWatch 287-2 Evaluation Study
Source: ClinicalTrials.gov · Last updated 26 Aug 2024
Brief summary (registry, in English)
In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions. Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic blood pressure monitor. Patients wear the wristband for 28 days. During this time, the number of atrial fibrillation episodes detected by the wristband is being counted, which is to be compared with the number of episodes detected by the holter. Also, blood pressure is measured continuously, which is to be compared with daily blood pressure measurements using a conventional blood pressure cuff.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 190 (actual)
- First submitted
- 2 Jun 2023
- Start date
- 15 Jun 2023
- Primary completion date
- 28 Dec 2023
- Lead sponsor
- Corsano Health B.V.
- Diseases
- Atrial fibrillation, High blood pressure
- NCT number
- NCT05899959
What you commit to
- Study type: Observational
- Participants enrolled: 190
- From 15 Jun 2023 to the primary completion date, 28 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Significant mental or cognitive impairment.
Other
- Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
- Pregnant women;
- Breastfeading women;
- Upper arm circumference not within the cuff range (22-42 cm)
- Unable or not willing to sign informed consent;
Who the study is looking for
- ≥ 18 years old;
- able to provide consent;
- receiving EKG holter or automatic blood pressure cuff for home monitoring per doctor prescription
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reinier de Graaf Gasthuis Coordinator of this site? Confirm its status | Delft | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.