Remote Monitoring of AF Recurrence Using mHealth Technology

NCT ID: NCT05037136

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-01-04

Brief Summary

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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.

Detailed Description

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Conditions

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Long Standing Persistent Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Birmingham

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shouvik Haldar

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield Hospitals, GSTT NHS Foundation Trust

Locations

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Royal Brompton and Harefield Hospitals, GSTT NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38774381 (View on PubMed)

Other Identifiers

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283058

Identifier Type: -

Identifier Source: org_study_id

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