Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation (VALIDATION)

East Limburg Hospital

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Heart rhythm measurements with Preventicus®; Diagnostic Test: Heart rhythm measurements with 6L Kardia Mobile®; Diagnostic Test: Heart rhythm measurements with FibriCheck®; Diagnostic Test: Heart rhythm measurements with Apple Watch®

Study type: Interventional

Funder types: Other

Identifiers

NCT06023290

Z-2023023

Details and patient eligibility

About

The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patient is an ambulatory cardiology patient.
• The patient is at least 18 years old.
• The patient is sinus or in atrial fibrillation.
• The patient is able to perform the study procedures together with the study assistant.

Exclusion criteria

• Patients with a pacemaker
• Inclusion in another clinical trial that may influence the results of this trial
• The patient is unable to comprehend the informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

126 participants in 1 patient group

Study population (single arm)

Other group

Treatment:

Diagnostic Test: Heart rhythm measurements with Apple Watch®

Diagnostic Test: Heart rhythm measurements with Preventicus®

Diagnostic Test: Heart rhythm measurements with 6L Kardia Mobile®

Diagnostic Test: Heart rhythm measurements with FibriCheck®