Overview
This is a cross-sectional observational study designed to assess the disease burden and quality of life in individuals with LQTS 2 and 3. Each participant will answer each patient-reported outcome questionnaire only once over a 6-month period. The study will enroll up to 200 participants.
Description
The aim of the present cross-sectional observational study is to evaluate the health status and quality of life burden in patients with LQTS. The total study duration is anticipated to last for a period of up to 18 months, including up to 6 months of each individual's observation period. The observation period may be extended by up to 3 months (total 9 months). During the optional extension, data collection via myQTwave will be limited to emotional and physical symptoms survey. This prospective cohort study will collect PRO information in a cohort of patients with LQTS 2 or 3. All screened participants will be assigned a unique identifier. Eligible participants will download the myQTwave app on the Apple iPhone and Apple Watch delivered to them after enrollment.
Patient-reported outcomes will be captured via the Apple iPhone and daily health metrics (sleep, physical and Heart-related data) will be collected using the Apple Watch.
Eligibility
Inclusion Criteria:
- The participant is willing and provides written informed consent to participate in this study.
- Male or female participant of at least 18 years of age, English-speaking.
- Confirmed genetic diagnosis of LQT2 or 3, demonstrated by one of the following:
- Genetic testing report (pathogenic or likely pathogenic (P/LP) mutation) in KCHN2 or SCN5a genes) or,
- A signed physician's letter confirming genetic diagnosis of LQTS 2 or 3.
- Documented QTc ≥ 480 ms within the last year, demonstrated by one of the following:
- 12-lead electrocardiogram (ECG), or
- A signed physician's letter confirming an ECG demonstrating QTc value ≥ 480 ms.
- The participant is able to operate a smartphone and a companion watch. \*The number of participants with QTc between 480 and 500 ms will be limited to 50.
Exclusion Criteria:
- Current participation in another clinical trial involving a drug or device.
- Participants unwilling to use an iPhone or Apple Watch for the duration of the study.
- Known diagnosis of Brugada Syndrome
- Participants unwilling to comply with outlined procedures.