Status:
TERMINATED
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Blue Ox Healthcare Partners
Minnesota Health Solutions
Conditions:
Long QT Syndrome
Eligibility:
All Genders
Up to 5 years
Phase:
NA
Brief Summary
The purpose of this study is to further develop and evaluate a diagnostic procedure suitable for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome (LQTS) in the p...
Detailed Description
The study will involve acquiring ECG data in a cohort of up to 1,000 newborns and infants (500 controls (non-LQTS) and 500 LQTS newborns and infants) that are being seen in the Gonda SL ECG Lab (or Ba...
Eligibility Criteria
Inclusion
- Infants (Day 0 - 5 years).
- Long QT Syndrome(LQTS).
- Newborns without LQTS (Controls).
- Parental willingness to provide informed consent and follow the study protocol.
Exclusion
- Children \> 5 years old.
- Those with genetically elusive LQTS.
- Infants with congenital heart disease.
- Infants born \< 32 weeks EGA.
- Patients with a cardiac device implant (pacemaker/ICD).
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04441892
Start Date
February 7 2019
End Date
March 26 2020
Last Update
July 25 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905