The objectives of this study are to acquire PPG data in AF patients simultaneously with reference measurements (ECG) and to develop interpretation algorithms of PPG features to detect AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are simultaneous ECG, PPG, and accelerometer
recordings that can be used to develop AF detection algorithms.
Secondary outcome
Not applicable.
Background summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Heart rhythm
monitoring in patients with AF is important for the following purposes:
assessing treatment efficacy for rate or rhythm control, evaluating safety and
efficacy of antiarrhythmic drug therapy and ablative procedures, finding the
correlation between documented arrhythmias and symptoms, and monitoring AF
burden to determine stroke risk. Moreover, there is a need for screening tools
that can detect silent AF in the elderly population, as this will help
preventing embolic stroke. The development of accurate detection of AF by
devices is imminent and ambulatory monitoring devices that provide long-term
monitoring capabilities, instant feedback, simplicity, every-day use, and a
non-invasive nature, are needed. Philips Research has developed wearable
technology based on photoplethysmography (PPG). This technology has the
potential to provide the basis for an accurate long-term ambulatory monitoring
device to detect AF that fits all the above stated criteria. The aim of this
study is to explore whether this technology can indeed be used to detect AF.
Study objective
The objectives of this study are to acquire PPG data in AF patients
simultaneously with reference measurements (ECG) and to develop interpretation
algorithms of PPG features to detect AF.
Study design
The study is an observational study.
Study burden and risks
The study will consist of two phases. The first phase is based on a simple
within-subject design. ECG and PPG data will be collected before (AF present)
and after (AF not present) elective electrical cardioversion in the same
patients. The second phase consists of a longer-term ECG and PPG (and
accelerometer) recording during daily living.
In Phase 1, the only addition to usual clinical care is that patients will be
wearing the ELAN wristband to collect PPG data and the Actiwave Cardio to
collect ECG data for about 30 min before and after cardioversion. Phase 2 will
be divided in two groups of patients. All will be patients who are undergoing
Holter recordings as part of their usual clinical care. In group 2A, the ELAN
wrist watch will be the only addition to usual clinical care. The second group
will consist of patients waiting for an ablation procedure who will be invited
to volunteer to undergo a short free-living simulation protocol at the start of
the Holter recording. This is not part of their usual clinical care.
There are no risks associated with this study. Most of the study does not
interfere with usual clinical care. The only addition will be the ELAN
wristband (and the Actiwave Cardio). Only in the third group, patients will be
asked to undergo a short (30-60 min) protocol of everyday activities, which is
not part of usual clinical care. The burden for the patients is minimal in all
cases.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must have been diagnosed with Atrial Fibrillation and either be scheduled to have an elective electrical cardioversion (Phase 1), or be scheduled for a Holter recording (Phase 2). For Phase 2B patients are eligible when they are waiting for an ablation procedure.
Exclusion criteria
A potential subject will be excluded from participation in this study if he/she is not able to provide informed consent.
Design
Recruitment
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 | NL53827.100.15 |