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Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation

NCT06023290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-12-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Heart rhythm measurements with Preventicus®

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

DIAGNOSTIC_TEST

Heart rhythm measurements with FibriCheck®

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

DIAGNOSTIC_TEST

Heart rhythm measurements with Apple Watch®

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

DIAGNOSTIC_TEST

Heart rhythm measurements with 6L Kardia Mobile®

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2023-10-27
Completion
2023-11-17

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023290 on ClinicalTrials.gov