REmote CArdiac MOnitoring by the Corsano CardioWatch 287-2 Evaluation Study

NCT05899959 | Completed

• 1 other identifier: RECAMO
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Rhythm; Disorder; Palpitations; Hypertension; Hypotension

Keywords

wristband; wearable; blood pressure; ekg; atrial fibrillation; hypertension; comparison

Outcome Measures

Primary Outcomes (2)

• Atrial fibrillation detection rate

  Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.

  28 days

• Blood pressure accuracy

  Mean systolic and diastolic blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.

  28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)

Secondary Outcomes (2)

• Blood pressure accuracy

  28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)

• Usability questionnaire

  28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)

Study Arms (2)

Patients receiving an EKG holter

patients receiving an EKG holter at the outpatient clinic for 24-48 hours of remote monitoring

Device: Corsano CardioWatch 287-2

Patients receiving an automatic blood pressure cuff

patients receiving an automatic blood pressure cuff at the outpatient clinic for 24 hours of remote monitoring

Device: Corsano CardioWatch 287-2

Interventions

Corsano CardioWatch 287-2 DEVICE

Patients receive either an EKG holter or an automatic blood pressure cuff, as prescribed by their cardiologist. The readings from these devices (atrial fibrillation detection and blood pressure) will be compared to the readings from the CardioWatch 287-2.

Patients receiving an EKG holter; Patients receiving an automatic blood pressure cuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One group (A) receiving an EKG monitoring holter for the duration of 24 hours as part of standard care for atrial fibrillation screening. Besides, one group (B) receiving an automatic blood pressure cuff for the duration of 24 hours as part of standard care for blood pressure evaluation.

You may qualify if:

• ≥ 18 years old;
• able to provide consent;
• receiving EKG holter or automatic blood pressure cuff for home monitoring per doctor prescription

You may not qualify if:

• Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
• 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;
• Significant mental or cognitive impairment.

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Location

Related Publications (2)

• van Vliet M, Aalberts JJJ, Hamelinck C, Hauer AD, Hoftijzer D, Monnink SHJ, Schipper JC, Constandse JC, Peters NS, Lip GYH, Steinhubl SR, Ronner E. Assessment of photoplethysmography-based blood pressure determinations during long-term and short-term remote cardiac monitoring: the RECAMO study. Eur Heart J Digit Health. 2025 Mar 27;6(4):763-771. doi: 10.1093/ehjdh/ztaf027. eCollection 2025 Jul.

  PMID: 40703134 DERIVED

• van Vliet M, Aalberts JJJ, Hamelinck C, Hauer AD, Hoftijzer D, Monnink SHJ, Schipper JC, Constandse JC, Peters NS, Lip GYH, Steinhubl SR, Ronner E. Ambulatory atrial fibrillation detection and quantification by wristworn AI device compared to standard holter monitoring. NPJ Digit Med. 2025 Mar 25;8(1):177. doi: 10.1038/s41746-025-01555-9.

  PMID: 40133622 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Hypertension; Hypotension

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 15, 2023
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)