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

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. 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. Accuracy of AF detection from PDL data
3. Technical development of algorithms to detect arrhythmia from data collected with these novel devices
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.

CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues:

1. 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?
2. What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF?
3. 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?
4. 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

Interventions

DEVICE

Smartphone application

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.

DEVICE

Bed sensor

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

DEVICE

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

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.

DEVICE

Patch-holter ECG

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.

Sponsors & Collaborators

• Philips Electronics Nederland BV

  collaborator INDUSTRY

• Everon Ltd

  collaborator UNKNOWN

• Precordior Ltd

  collaborator INDUSTRY

• Remotea Ltd

  collaborator UNKNOWN

• Emfit, Corp.

  collaborator INDUSTRY

• University of Turku

  lead OTHER

Principal Investigators

• Juhani KE Airaksinen, MD, PhD · Heart Center, Turku University Hospital and University of Turku, Turku, Finland

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-12

Primary Completion

2024-04-23

Completion

2025-01-31

Countries

• Finland

Study Locations