NCT06023290

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

July 4, 2023

Last Update Submit

November 30, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

  • Sensitivity

    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

    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

    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

    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 Outcomes (3)

  • Positive predictive value

    During the heart rhythm measurements

  • Negative predictive value

    During the heart rhythm measurements

  • Patient preference score (for the use of the diagnostic devices)

    During the heart rhythm measurements

Other Outcomes (1)

  • Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis

    During the heart rhythm measurements

Study Arms (1)

Study population (single arm)

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

Interventions

Heart rhythm measurements with Preventicus®DIAGNOSTIC_TEST

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.

Study population (single arm)
Heart rhythm measurements with FibriCheck®DIAGNOSTIC_TEST

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.

Study population (single arm)
Heart rhythm measurements with Apple Watch®DIAGNOSTIC_TEST

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.

Study population (single arm)
Heart rhythm measurements with 6L Kardia Mobile®DIAGNOSTIC_TEST

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.

Study population (single arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a pacemaker
  • The patient is unable to comprehend the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2023

First Posted

September 5, 2023

Study Start

July 3, 2023

Primary Completion

October 27, 2023

Study Completion

November 17, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

BE(1)