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OpenTrials
Completed

NCT Number: NCT05037136

Remote Monitoring of AF Recurrence Using mHealth Technology

Atrial fibrillation (AF) is the most common arrhythmia worldwide. It carries a significant health burden, conferring on sufferers a reduction in quality of life, risk of significant morbidities such as stroke and heart failure, and significant mortality. At present, diagnosis of AF involves referral for conventional 12 lead electrocardiogram (ECG) recording, ambulatory ECG for fixed time period recording, or insertion of implantable loop recorders (ILR). These investigations are limited both by recording only at specific time points and failing to explore the interaction between heart rate and day-to-day physical activity. In recent years, the use of mobile health (mHealth) devices has emerged as a direct-to-consumer option for monitoring parameters such as heart rate and activity levels. From a clinical perspective they potentially offer a less invasive and cost-effective investigative approach, with remote monitoring solution to identify and possibly predict AF. In this study, the investigators propose to recruit participants who have undergone an ablative procedure as part of a randomised clinical trial (LoTO in CASA LSPAF: NCT04280042) and monitor for recurrence of AF using mHealth technology by correlating with ILR data.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton and Harefield Hospitals, GSTT NHS Foundation Trust

London, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in LoTO in CASA LSPAF with implanted loop recorders (ILR)

Exclusion criteria

  • Participants in LoTO in CASA LSPAF who had their ILR explanted

Treatment and study plan

Primary outcomes

  1. To explore if mHealth obtained heart rate (PPG) data can be correlated to recurrence of AF/AT in patients who have undergone an ablative procedure.

    Time frame: 18 months

    Exploring a correlation between PPG data from a wrist worn device and atrial arrhythmias recorded by implantable loop recorder or other clinically indicated rhythm recording device.

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

Remote Monitoring of AF Recurrence Using mHealth Technology (REMOTE-AF)

Acronym: REMOTE-AF

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 8, 2021
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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