Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT03509493
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
Sponsor:
Qompium NV
Organization:
Study Overview
Official Title:
Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. FibriCheck is only available on prescription causing the physician to stay in the 'driving seat' and the application distribution to be traced.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
* Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
* Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
* Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
* Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
Detailed Description:
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 50 million people in Europe and the U.S. It is associated with an increasing mortality and risk for transient cerebrovascular incidents and dementia. De novo AF is in most cases asymptomatic and paroxysmal, causing the diagnosis to be made either by chance or in response to an incident. This drastically impacts the quality of life of the patient and is accompanied with a high socio-economic cost. Guidelines indicate that anticoagulation in patients diagnosed with AF is a cost-effective solution for the prevention of strokes.
In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
* Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
* Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of "an application on prescription".
Short- and long-term benefits the project wants to prove:
Short-term:
\- AF can successfully be detected in a home environment using the FibriCheck application
Long-term: a successful detection of AF in a home environment can:
* Be the first step towards changing and improving the care pathway of the patient
* Induce therapeutic interventions in order to prevent strokes or other complications
In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely.
By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:
* Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
* Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment
The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of "an application on prescription".
Short- and long-term benefits the project wants to prove:
Short-term:
\- AF can successfully be detected in a home environment using the FibriCheck application
Long-term: a successful detection of AF in a home environment can:
* Be the first step towards changing and improving the care pathway of the patient
* Induce therapeutic interventions in order to prevent strokes or other complications
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: