Remote Monitoring of AF Recurrence Using mHealth Technology

Long Standing Persistent Atrial Fibrillation Clinical Trial

— REMOTE-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037136
• Other study ID #: 283058
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: January 4, 2023

Study information

• Verified date: May 2023
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 4, 2023
• Est. primary completion date: December 4, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Long Standing Persistent Atrial Fibrillation
• Recurrence

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield Hospitals, GSTT NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	18 months