To demonstrate that in patients with a CHA2DS2-VASc score of 2 or higher and no history of AF, the use of the Preventicus Heartbeats App increases the detection rate of AF compared to usual care and to demonstrate that AF screening with the app is…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the prevalence of AF confirmed by ECG in
the app group compared with the standard care group
Secondary outcome
The main secondary study outcomes are costs related to the AF screening with
the app and the compliance in each study group
Background summary
The Preventicus Heartbeats Application is a comprehensively clinically
validated and CE marked medical device. It uses the smartphone LED light and
camera to record a person*s pulse wave at the fingertip. Using proprietary
algorithms, the pulse wave signals are then analysed and translated into an
ECG-comparable readout for clinical evaluation. Previous clinical studies
demonstrated, that the Preventicus Heartbeats App reached an accuracy of 96%
and a positive predictive value of 99% for detection of atrial fibrillation
Study objective
To demonstrate that in patients with a CHA2DS2-VASc score of 2 or higher and no
history of AF, the use of the Preventicus Heartbeats App increases the
detection rate of AF compared to usual care and to demonstrate that AF
screening with the app is cost-effective
Study design
Multicentre, international, investigator-initiated, controlled, randomised,
double-blind clinical validation study of a smartphone application as screening
tool for differentiation between sinus rhythm and atrial fibrillation
AF screening with a smartphone application will be assessed in a double-blind
randomised controlled trial. Patients will be randomly allocated in the
intervention group *app* or control group *usual care*. All patients in both
groups will receive the app and will be asked to perform a predefined
measurement protocol. Investigators will be informed by Preventicus® if
participants fail to provide the measurements according to the measurement
protocol
App Measurement Protocol Study Time Duration 6 Months = 26 Weeks
App Use Weeks 1-2 Weeks 3-26
Frequency 2 x Day 2 x Week, on different days
Always in case of palpitations
Duration Approx. 1 minute each time
Procedure Place fingertip on the camera lens of the smartphone
Study burden and risks
Flashlight of the smartphone is active during measurement. This might cause
some warmth release that might cause some skin irritation or pain at the
finger tip
Petersgraben 4
Basel CH-4031
CH
Petersgraben 4
Basel CH-4031
CH
Listed location countries
Age
Inclusion criteria
signed informed consent
• CHA2DS2-VASc score * 3, if patients less than 65 years old
• CHA2DS2-VASc score * 2, if patients 65 years or more
Exclusion criteria
• history of AF
• current anticoagulation treatment,
• cardiac implanted electronic device (ICD or/and PM)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04108884 |
| CCMO | NL72798.068.20 |