Recruiting NCT06887387
Wearable Devices for Patient Monitoring in Long QT Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable device.
- Who it may be relevant to
- Registry conditions: Long QT Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Application of Wearable Devices for Remote QT Interval Monitoring and Symptom Investigation for Patients With Long QT Syndrome
Overview
The main research question of this study is whether wearable devices have utility in monitoring patients with Long QT syndrome.
Interventions
- Device Wearable device
This is an observational study that does not impact routine clinical care for participants
Primary outcome measures
- 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) [Time frame: From enrollment to 3 months]
- 2. Establish intra-patient QT variability from weekly Fitbit-ECGs and frequency of measurements over 500ms. [Time frame: From enrollment to 3 months]
Secondary outcome measures (2)
- 1. Establish the utility of wearable devices for determining symptom aetiology in LQTS. [Time frame: 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. [Time frame: From enrollment to 3 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Unwilling or unable to give consent
- Ventricular pacing at recruitment
- Bundle branch block or pre-excitation at baseline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Barts and London Hospital NHS Trust — London
Identifiers
NCT: NCT06887387 · 173178