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

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

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.

Study Overview

• Status: Completed
• Conditions: Long Standing Persistent Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Royal Brompton and Harefield Hospitals, GSTT NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with long standing persistent atrial fibrillation who have undergone an ablative procedure for the condition and who were implanted with a loop recorder to monitor their heart rhythm as part of their participation in LoTO in CASA LSPAF (NCT04280042)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Ablation; Participants recruited from the LoTO_CASA_AF trial (ClinicalTrials.gov Identifier: NCT04280042) who underwent either conventional catheter ablation or thoracoscopic surgical ablation to treat their long standing persistent AF with be asked to continue downloading data from their implanted loop recorder and monitor their heart rate and physical activity level (step count) using a wrist worn activity tracker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: University of Birmingham
• Investigators: Principal Investigator: Shouvik Haldar, Royal Brompton & Harefield Hospitals, GSTT NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 4, 2022
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Catheter ablation; Artificial intelligence; Digital health; Thoracoscopic surgical AF ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 283058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No