Remote Monitoring of AF Recurrence Using mHealth Technology

NCT05037136 | Completed

• 1 other identifier: 283058
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long Standing Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Digital health; Artificial intelligence; Catheter ablation; Thoracoscopic surgical AF ablation

Outcome Measures

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.

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• University of Birmingham: collaborator

Study Sites (1)

Royal Brompton and Harefield Hospitals, GSTT NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

• Adasuriya G, Barsky A, Kralj-Hans I, Mohan S, Gill S, Chen Z, Jarman J, Jones D, Valli H, Gkoutos GV, Markides V, Hussain W, Wong T, Kotecha D, Haldar S. Remote monitoring of atrial fibrillation recurrence using mHealth technology (REMOTE-AF). Eur Heart J Digit Health. 2024 Feb 12;5(3):344-355. doi: 10.1093/ehjdh/ztae011. eCollection 2024 May.

  PMID: 38774381 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shouvik Haldar

  Royal Brompton & Harefield Hospitals, GSTT NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: August 1, 2020
• Primary Completion: December 4, 2022
• Study Completion: January 4, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)