Aim: To determine the specificity and sensitivity of the AF app to detect AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The determination of sensitivity and specificity for detection of AF using a
PPG based smartphone application.
Secondary outcome
1. To determine the accuracy of the PPG based smartphone application to
discriminate between other arrhythmias besides AF
2. Register external factors that effect the accuracy of the measurements.
Background summary
Atrial fibrillation (AF) is a cardiac arrhythmia characterised by continuous
atrial activity and resulting in an irregular ventricular heart rhythm. It is
the most common continuous arrhythmia and it affects more than 250.000 patients
in the Netherlands. (Bots et al., 2015). The prevalence increases sharply with
age and increases towards 7-10% in octogenarians. AF can be asymptomatic or
result in irregular palpitations, dyspnoea or fatigue.
Depending of several risk factors complications of atrial fibrillation can
occur, these include:
- Stroke due to dislodgement of a left atrial thrombus. (formation
primarily in the left atrial appendage) In pacemaker patients it has been shown
that even short episodes of AF (>6 minutes) are associated with an increased
risk of stroke. (Benezet-Mazuecos, J et al., 2015) The risk of stroke can be
significantly reduced by the use of oral anticoagulation. (Kirchhof, P et al.,
2016)
- Heart failure can occur, especially when AF results in rapid
ventricular contractions.
Early detection of AF is important in order to be able to initiate appropriate
therapy to prevent stroke and heart failure. AF can be easily diagnosed using
an electrical rhythm recording. New smartphone technology has introduced a new
method to detect heart rhythm: photophletysmographic (PPG) recording of the
blood pulse in the finger (Gregoski, M. J., et al., 2012). PPG uses variation
in reflection of light against tissue to measure the rhythm of blood perfusing
the tissue. The AF-app is a novel software application for smartphone that uses
PPG to detect cardiac arrhythmias including AF.
Study objective
Aim: To determine the specificity and sensitivity of the AF app to detect AF.
Study design
This is a prospective case-control study evaluating the AF app by comparing two
non-invasive diagnostic methods. Patients with AF serve as their own control by
taking measures before and after successful cardioversion.
Study burden and risks
Patients will undergo standard electrocardiographic heart rhythm monitoring. As
part of the study an additional smartphone based heart rhythm measurement will
be performed. There are no risks related to this research.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
Patients > 18 years with atrial fibrillation admitted for elective cardioversion for atrial fibrillation or who present with other intermittent arrhythmias
Exclusion criteria
- Patients unwilling to participate
- Patients with >1% ventricular pacing by a pacemaker
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 | NL60442.100.17 |