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

NCT04563572 | Completed

• 1 other identifier: 2020-01983
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Wearables; AF Burden; Photoplethysmography (PPG); Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• AF Burden

  48 hours

• Asymptomatic AF episodes

  48 hours

Study Arms (2)

PPG Smartwatch

EXPERIMENTAL

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

PPG Bracelet

EXPERIMENTAL

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

Interventions

PPG Smartwatch DEVICE

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.

PPG Bracelet; PPG Smartwatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Preventicus GmbH: collaborator
• Manufacture Modules Technologies SA: collaborator
• GETEMED GmbH: collaborator
• Eurostars: collaborator

Study Sites (1)

Universitiy Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• Reissenberger P, Serfozo P, Piper D, Juchler N, Glanzmann S, Gram J, Hensler K, Tonidandel H, Borlin E, D'Souza M, Badertscher P, Eckstein J. Determine atrial fibrillation burden with a photoplethysmographic mobile sensor: the atrial fibrillation burden trial: detection and quantification of episodes of atrial fibrillation using a cloud analytics service connected to a wearable with photoplethysmographic sensor. Eur Heart J Digit Health. 2023 Jul 6;4(5):402-410. doi: 10.1093/ehjdh/ztad039. eCollection 2023 Oct.

  PMID: 37794868 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Eckstein, MD, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: October 13, 2020
• Primary Completion: July 28, 2022
• Study Completion: July 30, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)