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

Paroxysmal Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563572
• Other study ID #: 2020-01983
• Status: Completed
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: July 30, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Universitiy Hospital Basel	Basel	Basel-Stadt

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Eurostars, GETEMED GmbH, Manufacture Modules Technologies SA, Preventicus GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AF Burden	Cumulative duration of AF episodes	48 hours
Secondary	Asymptomatic AF episodes	Number of asymptomatic AF episodes	48 hours