The primary objective of this trial is to quantify the incidence of AF in patients at high risk for but without previously known AF using a smartwatch wearable with a photoplethysmographic sensor and to determine if the incidence is higher compared…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the incidence of atrial fibrillation detected by
the PPG sensor and Apple algorithm and diagnosed by a cardiologist
(intervention group) or by standard care alone.
Secondary outcome
The secondary outcomes are time to event, the initiation of therapies for AF,
the number of patients with major adverse cardiovascular events, other
arrhythmias than AF diagnosed by a cardiologist, predictors of AF and number of
emergency department visits during the study period.
Background summary
Atrial fibrillation (AF) is the most common arrhythmia in the elderly
population and has become one of the most important public health issues and
causes of health expenditures in Europe over the last two decades. People with
AF may present with symptoms, but asymptomatic episodes are also possible,
especially in paroxysmal AF, where an episode of AF terminates spontaneously
and could remain undiagnosed until complications such as stroke occur. The lack
of continuous heart rate monitoring options makes early diagnosis of AF
challenging. In this trial, a PPG smartwatch wearable (Apple Watch series 5 or
8) will be used to conduct continuous heart rate and -rhythm monitoring in
cardiac patients with a known high risk of developing AF (ChadsVasc score >= 2
men; >=3 women; age >= 65). Collected data will be transferred to a smartphone
ECG-application (Apple) and analysed by an algorithm (Apple). All equipment has
been clinically validated and CE marked for this use. A control group will
follow their standard
care and is investigated to give insight in the role of adding a PPG smartwatch
to standard care. The aim of this trial is to identify, diagnose and treat
otherwise undetected AF in a high-risk group of cardiac patients and thereby
lower the risk of future complications of AF.
Study objective
The primary objective of this trial is to quantify the incidence of AF in
patients at high risk for but without previously known AF using a smartwatch
wearable with a photoplethysmographic sensor and to determine if the incidence
is higher compared to patients receiving standard care alone.
Study design
A monocenter, prospective randomized conrolled trial in high-risk cardiac
patients (ChadsVasc score >= 2 men; >=3 women; age >=65).
Study burden and risks
Participants in the intervention group are requested to wear an Apple watch for
a minimum of 12 hours a day, which will be handed to them during a screening
visit. Simultaneously, they will need to have a connected smartphone with them.
When an irregular heartbeat is detected by the PPG signal, patients are
notified on the smartwatch and requested to record a single-lead ECG of 30
seconds. If necessary, participants may be asked to visit one of the outpatient
clinics of the Investigator for additional testing. In case of symptoms or
distress participants are instructed to contact a physician or the emergency
number. Patients are requested to perform extra measurements if symptoms occur.
After the monitoring period of 6 months, an evaluation visit is scheduled in
which the devices will be returned to the Investigator. Patients in the control
group will receive their standard care alone and will not wear an Apple Watch.
The risks of participation are negligible for all patients. The study
requirements for careful selection, training, and
monitoring of the participants for 6 months carry potential benefits that might
not be present if the subject received the device without participating in the
study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- High risk, defined as patient ChadsVasc >=2 for men and or >=3 women at time of
eligibility screening
- Patient age >= 65 years at time of eligibility screening
- Possession of iPhone (5s or later) with iOS version 11.0 or later defined as
iPhone model/iOS version used to complete screening eligibility
Exclusion criteria
- Diagnosis of Atrial fibrillation or Atrial Flutter
- Currently on anticoagulation therapy
- Cardiac implanted electronic device (Pacemaker, ICD)
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 |
|---|---|
| CCMO | NL79151.018.21 |