Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation

University Hospital Basel

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: PPG Smartwatch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04563572

2020-01983

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

PPG Smartwatch

Experimental group

Description:

The Preventicus Heartbeats algorithm ist a certified tool for detection of Atrial Fibrillation. It differentiates accurately between regular rhythm, single premature beats and the absolute arrhythmia concordant with AF. The Preventicus algorithm is device-agnostic, meaning that any wearable device capable of recording PPG-signals can be used for data collection. CardioWatch 287 is a novel non-invasive monitoring device manufactured by the MMT company. The device monitors heart rhythm, heart rate (HR) and respiratory rate (RR) based on peripheral PPG signal. In this arm, we will test the quality of the algorithm integrated into the smartwatch.

Treatment:

Device: PPG Smartwatch

PPG Bracelet

Experimental group

Description:

The Preventicus Heartbeats algorithm ist a certified tool for detection of Atrial Fibrillation. It differentiates accurately between regular rhythm, single premature beats and the absolute arrhythmia concordant with AF. The Preventicus algorithm is device-agnostic, meaning that any wearable device capable of recording PPG-signals can be used for data collection. A PPG-sensor is also integrated into a bracelet "Basler Band" manufactured by the MMT company, which is a simplified multisensory device. In this arm, we will test the quality of the algorithm integrated into the bracelet.

Treatment:

Device: PPG Smartwatch