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

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

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: PPG Smartwatch

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitiy Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPG Smartwatch; 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.	Device: PPG Smartwatch; Participants will then receive a PPG sensor in form of a smartwatch) model and will be instructed to wear them continuously for 48 hours. Simultaneously, a 48-hour Holter ECG will be performed. Start time on the PPG-sensor and the Holter ECG will be matched and continuous heart rhythm and -rate monitoring will be initiated. Patients will wear the devices over a 48-hour period of time.
Experimental: PPG Bracelet; 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.	Device: PPG Smartwatch; Participants will then receive a PPG sensor in form of a smartwatch) model and will be instructed to wear them continuously for 48 hours. Simultaneously, a 48-hour Holter ECG will be performed. Start time on the PPG-sensor and the Holter ECG will be matched and continuous heart rhythm and -rate monitoring will be initiated. Patients will wear the devices over a 48-hour period of time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of AF episodes	Number of detected atrial fibrillation episodes by the PPG sensor and Preventicus Heartbeats algorithm during the 48h trial period compared to the Holter ECG.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF Burden	Cumulative duration of AF episodes	48 hours
Asymptomatic AF episodes	Number of asymptomatic AF episodes	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Eurostars; Preventicus GmbH; Manufacture Modules Technologies SA; GETEMED GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Wearables; AF Burden; Photoplethysmography (PPG)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2020-01983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No