Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients At High Risk of AF and Stroke

NCT05351775 | Completed DMC

• 1 other identifier: MOORE4MEDICAL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment. The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. CARE-DETECT algorithm development part I will investigate following topics:

1. 1.The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG)
2. 2.Accuracy of AF detection from PDL data
3. 3.Technical development of algorithms to detect arrhythmia from data collected with these novel devices
4. 4.Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation.
5. 5.Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure?
6. 6.What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF?
7. 7.Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods?
8. 8.Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Postoperative Complications

Keywords

Wearable Cardiac Devices; Bed Sensor; Mobile Application; Rhythm Monitoring; Photoplethysmography; Accelerometer; Atrial Fibrillation Screening; Algorithm Development; Silent Atrial Fibrillation; Stroke; Mortality; Economic Evaluation

Outcome Measures

Primary Outcomes (8)

• The rate of new AF during index hospitalization.

  AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.

  During hospital stay (assessed up to 10 days).

• The rate of new AF burden during index hospitalization.

  AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.

  During hospital stay (assessed up to 10 days).

• The rate of new AF during 3 months follow-up after index hospitalization.

  AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.

  During 3 months follow-up.

• The rate of new AF burden during 3 months follow-up after index hospitalization.

  AF defined by 12-lead ECG or ECG-holter adjudicated by a cardiologist and in borderline cases by two independent cardiologists.

  During 3 months follow-up.

• Algorithm development.

  The gold standard reference (ECG or Holter) data will be collected to develop an algorithm to detect AF from PPG data.

  The part I trial during index hospitalization (assessed up to 48 hours). The part I trial with PDL may be continued among the part II interventional group during initial hospitalization (assessed up to 10 days) in order to collect additional data.

• Number of adverse events related to PDL device.

  Although the PDL is safe to use, the user may experience adverse reactions. This is due to wearing the device in contact with the skin for long periods at a time. These reactions include: skin reactions due to pressure of the device on the skin or the device rubbing against the skin, skin reactions due to dirt or moisture in between the device and the skin, skin irritation due to the materials used (colored acrylonitrile butadiene styrene (ABS) and thermoplastic polyurethane (TPU)).

  The part I trial during index hospitalization (assessed up to 48 hours). The part I trial with PDL may be continued among the part II interventional group during initial hospitalization (assessed up to 10 days) in order to collect additional data.

• Number of technical issues of the concept and interface.

  In part I study the bed sensor technology and mobile phone application will be tested and validated in an open set-up to reliability of the devices and applications before starting the randomized part II of the trial.

  The part I trial during index hospitalization (assessed up to 48 hours).

• Number of practical issues of the concept and interface.

  In part I study the bed sensor technology and mobile phone application will be tested and validated in an open set-up to usability of the devices and applications before starting the randomized part II of the trial.

  The part I trial during index hospitalization (assessed up to 48 hours).

Secondary Outcomes (4)

• All-cause mortality.

  During 12 months follow-up.

• Number of Participants with Stroke, TIA and peripheral embolism.

  During 12 months follow-up.

• Additional costs per detected case of new AF.

  During 12 months follow-up.

• Number of participants adherent to anticoagulant treatment.

  During 12 months follow-up.

Other Outcomes (1)

• The rate of new AF in long-term follow-up after index hospitalization.

  During average 3 years follow-up.

Study Arms (2)

Interventional AF detection arm

EXPERIMENTAL

The patients will be monitored during index hospitalization according normal practice and additionally with a bed sensor, smartphone app, and patch-holter ECG. In addition, patients will have PDL monitoring device during hospitalization. During the index hospitalization, patients will download the CardioSignal app to their own smartphone or if patient does not have a smartphone one can be provided to the patient by the study group. Patients are asked to do the first recordings at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period. When discharged home, the study subject will have the bed sensor for home-based use up to 3 months. If the average pulse rate in the bed sensor recordings have increased with 20% or the device has recorded rhythm irregularity lasting over 5 minutes (could be longer to reduce false alarms), a 12-lead ECG will be taken, and in the case of a normal ECG, a 7-day Holter monitoring is performed.

Device: Smartphone application; Device: Bed sensor; Device: Wrist-worn photoplethysmography (PPG) and accelerometer data logger.; Device: Patch-holter ECG

Standard of care treatment arm

NO INTERVENTION

Patient will be followed as in routine clinical practice.

Interventions

Smartphone application DEVICE

Patient is asked to do the first recording at hospital to test the device and then preferably twice daily for 1 minute period of time during the 3-month study period.

Also known as: CardioSignal app

Interventional AF detection arm

Bed sensor DEVICE

The Emfit bed sensor will be used during the index hospitalization and in home-based monitoring after hospital discharge up to 3 months.

Also known as: Emfit sensor

Interventional AF detection arm

Wrist-worn photoplethysmography (PPG) and accelerometer data logger. DEVICE

Data collection with PDL is continued during initial hospitalization in the intervention group where the gold standard ECG is obtained and data can be used in algorithm development but will not be used to monitor treatment or for diagnosis.

Also known as: Philips Data Logger

Interventional AF detection arm

Patch-holter ECG DEVICE

The patch-holter will be used during the index hospitalization and also in home if the home-based monitoring devices are signalling of a possible AF and it is not detected in the consequent ECG.

Also known as: Faros Holter

Interventional AF detection arm

Eligibility Criteria

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

You may qualify if:

• One of listed cardiac operation performed during the index hospitalization:
• open heart surgery (aortic valve replacement (AVR), coronary artery bypass graft (CABG) or combination treatment) or
• percutaneous intervention (transcatheter aortic valve implantation (TAVI) or percutaneous coronary intervention (PCI))
• Patient has been informed on the nature of the study, agrees to its provisions and has provided written informed consent approved by the appropriate Medical Ethics committee.
• In PCI group, the randomization may take place after operation
• Age ≥18 years
• CHA2DS2VASC score ≥ 4, or CHA2DS2VASC score ≥ 2 and at least one of the following: ECG P wave duration ≥ 120 ms, left atrial diameter \> 38 mm in women or \> 40 mm in men, renal impairment (eGFR \< 50 ml/min), age ≥ 70 years, active smoking
• Anticipated life expectancy 12 months or more
• Patient is capable of using the study application and bed sensor
• Patient is willing to comply with study specific follow-up evaluations and home-based monitoring

You may not qualify if:

• Age \< 18 years
• Expected survival \< 1 year
• Permanent anticoagulation therapy due to atrial fibrillation
• Patient lives outside the catchment area
• Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.

Sponsors & Collaborators

• University of Turku: lead
• Philips Electronics Nederland BV: collaborator
• Everon Ltd: collaborator
• Precordior Ltd: collaborator
• Remotea Ltd: collaborator
• Emfit, Corp.: collaborator

Study Sites (1)

Heart Center, Turku University Hospital

Turku, FI-20520, Finland

Location

Related Publications (3)

• Fabritz L, Guasch E, Antoniades C, Bardinet I, Benninger G, Betts TR, Brand E, Breithardt G, Bucklar-Suchankova G, Camm AJ, Cartlidge D, Casadei B, Chua WW, Crijns HJ, Deeks J, Hatem S, Hidden-Lucet F, Kaab S, Maniadakis N, Martin S, Mont L, Reinecke H, Sinner MF, Schotten U, Southwood T, Stoll M, Vardas P, Wakili R, West A, Ziegler A, Kirchhof P. Expert consensus document: Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment. Nat Rev Cardiol. 2016 Apr;13(4):230-7. doi: 10.1038/nrcardio.2015.194. Epub 2015 Dec 24.

  PMID: 26701216 BACKGROUND

• Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.

  PMID: 24963567 BACKGROUND

• Jaakkola J, Mustonen P, Kiviniemi T, Hartikainen JE, Palomaki A, Hartikainen P, Nuotio I, Ylitalo A, Airaksinen KE. Stroke as the First Manifestation of Atrial Fibrillation. PLoS One. 2016 Dec 9;11(12):e0168010. doi: 10.1371/journal.pone.0168010. eCollection 2016.

  PMID: 27936187 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Postoperative Complications; Stroke

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Juhani KE Airaksinen, MD, PhD

  Heart Center, Turku University Hospital and University of Turku, Turku, Finland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The part I trial is open, prospective interventional trial. These recordings are used merely to technical testing, validity evaluation and algorithm development purposes and the data is not used in any clinical evaluation whatsoever. The part II is a prospective, randomized, open-label, interventional study. Upon receipt of the signed written informed consent and satisfactory documentation that the patient met all inclusion and had no exclusion criteria, the study subjects will be randomized to either intervention or control arm. The randomization allocation will take into account the procedure subgroup of the patient (open-heart surgery, aortic valve replacement and transcatheter aortic valve implantation (TAVI) or coronary bypass and percutaneous coronary intervention (PCI)). In both subgroups the randomization will be done 1:1. Patients will be randomized before hospital discharge.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 28, 2022
• Study Start: April 12, 2022
• Primary Completion: April 23, 2024
• Study Completion: January 31, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)