Clinical trial NCT04563572: Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation
Official title: Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation Using a Cloud Analytics Service Connected to a Wearable With Photoplethysmographic (PPG) Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Wearables
AF Burden
Photoplethysmography (PPG)
Atrial Fibrillation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Preventicus GmbH
name: Manufacture Modules Technologies SA
name: GETEMED GmbH
name: Eurostars
First posted: 2020-09-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will receive a PPG sensor in form of a smartwatch or a bracelet and will be instructed to wear them continuously for 48 hours. Assigning patients to the smartwatch or the bracelet group will occur in an alternating fashion.
Primary purpose: DIAGNOSTIC

Brief summary: In this prospective single-center trial, a wearable photoplethysmographic (PPG) sensor coupled with a cloud analytics service will be used to detect and quantify atrial fibrillation (AF) episodes in patients with known paroxysmal AF. Patients will simultaneously receive the PPG sensor in form of a smartwatch or bracelet and a Holter ECG for 48 hours. Correctly identified AF episodes and AF burden determined by both methods will be compared.

Detailed description: Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major risk factor for cerebrovascular insults. Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days. Patients with AF may present with palpitations, shortness of breath or sensation of light-headedness but asymptomatic episodes are also possible, especially in paroxysmal AF. The lack of continuous heart rate monitoring options makes early diagnosis of paroxysmal AF challenging. In this prospective single-center trial, the PPG wearable Corsano CardioWatch 287 sensor will be used to conduct continuous heart rate and -rhythm monitoring in patients with known paroxysmal AF. Collected data will then be analysed using a Cloud Analytics Service (Preventicus Heartbeats algorithm) and compared with data from simultaneously obtained 48-hour Holter ECG. Correctly identified AF episodes, their cumulative duration per 48 hours (AF burden) and the number of asymptomatic episodes will be assessed. In the primary analyses, the sensitivity of the PPG analysing algorithm to detect AF episodes is estimated by performing a logistic regression on detection (yes/no) with only an intercept as predictor, which is then translated to a proportion (the sensitivity). In the secondary analyses we are comparing the cumulative duration of AF episodes over 48 hours (AF burden) obtained with the PPG-sensor and Holter-ECG. In summary, the purpose of the study is to evaluate the performance and efficacy of the wearable PPG sensor and the cloud analytics service in detecting and quantifying AF episodes in patients with known history of paroxysmal AF.

Eligibility criteria: Inclusion Criteria:

* Known paroxysmal atrial fibrillation
* Patient ≥ 18 years old
* Written informed consent as documented by signature from the patient

Exclusion Criteria:

* Cardiac implanted electronic device (Pacemaker, ICD)
* Smartwatch/Bracelet and/or ECG device cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
* Patients unable or not willing to sign informed consent Significant mental or cognitive impairment

Primary outcomes:
measure: Number of AF episodes
timeFrame: 48 hours
Secondary outcomes:
measure: AF Burden
timeFrame: 48 hours
measure: Asymptomatic AF episodes
timeFrame: 48 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitiy Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: