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

November 30, 2023 updated by: Ziekenhuis Oost-Limburg
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study population (single arm)
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: During the heart rhythm measurements
Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.
During the heart rhythm measurements
Specificity
Time Frame: During the heart rhythm measurements
Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.
During the heart rhythm measurements
Accuracy
Time Frame: During the heart rhythm measurements
Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
During the heart rhythm measurements
Cramer's V
Time Frame: During the heart rhythm measurements
The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.
During the heart rhythm measurements

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preference score (for the use of the diagnostic devices)
Time Frame: During the heart rhythm measurements
This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.
During the heart rhythm measurements
Positive predictive value
Time Frame: During the heart rhythm measurements
Proportion of true positive tests out of all positive tests.
During the heart rhythm measurements
Negative predictive value
Time Frame: During the heart rhythm measurements
Proportion of true negative tests out of all negative tests.
During the heart rhythm measurements

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis
Time Frame: During the heart rhythm measurements
The proportion of true positive tests, true negative tests and the association of between the classification of the test devices and 12-lead ECG.
During the heart rhythm measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Z-2023023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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