Wearable Devices for Patient Monitoring in Long QT Syndrome

NCT06887387 | Recruiting DMC

• 1 other identifier: 173178
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The main research question of this study is whether wearable devices have utility in monitoring patients with Long QT syndrome.

Conditions

Long QT Syndrome

Outcome Measures

Primary Outcomes (2)

• 1. Determine the accuracy of repeated QT interval measurements using Fitbit-derived ECGs in patients with Long QT syndrome compared with the current standard (12-lead ECG and ambulatory monitors)

  From enrollment to 3 months

• 2. Establish intra-patient QT variability from weekly Fitbit-ECGs and frequency of measurements over 500ms.

  From enrollment to 3 months

Secondary Outcomes (2)

• 1. Establish the utility of wearable devices for determining symptom aetiology in LQTS.

  From enrollment to 3 months

• 2. Develop pipelines for the analysis of ECG data collected remotely including use of in-house QT automated algorithms for future machine learning applications.

  From enrollment to 3 months

Interventions

Wearable device DEVICE

This is an observational study that does not impact routine clinical care for participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of long QT syndrome

You may qualify if:

• Clinical diagnosis of Long QT Syndrome
• Aged 18 years or over
• Phone with iOS version 15 or Android OS 9.0 or higher
• Able and willing to provide informed consent

You may not qualify if:

• Unwilling or unable to give consent
• Ventricular pacing at recruitment
• Bundle branch block or pre-excitation at baseline

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts and London Hospital NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Long QT Syndrome

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• William J Young, MBBS, PhD

  Queen Mary University of London and St Bartholomew's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)