Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System

Launched by CORSANO HEALTH B.V. · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a wristband device called the Corsano CardioWatch 287-2, which monitors heart rhythms to help detect a condition known as atrial fibrillation (AF). Atrial fibrillation is a type of irregular heartbeat that can lead to serious health issues. The trial aims to see how well this wristband works at identifying AF compared to traditional heart monitoring methods like a 12-lead ECG or a 24-hour Holter monitor. Researchers will involve patients in different groups, including those who are already being monitored for heart issues and those who have been diagnosed with AF.

To be eligible for this study, participants need to be at least 22 years old and should have symptoms related to heart rhythm problems or a previous diagnosis of arrhythmia. They must also be comfortable communicating in Dutch or English. Participants can expect to wear the wristband while continuing their usual activities, and the study will help determine how effective this new technology is in real-life situations. It’s important to note that the trial is not yet recruiting participants, and safety is a priority, so some individuals may not be able to participate based on their health conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation
• • Age ≥ 22 years old
• • Able to provide informed consent.
• • Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.
• Exclusion Criteria:
• • Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;
• • Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
• • Unable or not willing to receive ECG monitoring;
• • Unable or not willing to sign informed consent;