Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 primary care environment.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 5
Healthy Volunteers: f
View:
• Infants (Day 0 - 5 years).
• Long QT Syndrome(LQTS).
• Newborns without LQTS (Controls).
• Parental willingness to provide informed consent and follow the study protocol.
Locations
United States
Minnesota
Mayo Clinic in Rochester
Rochester
Time Frame
Start Date: 2019-02-07
Completion Date: 2020-03-26
Participants
Target number of participants: 33
Treatments
Experimental: QTc Meter
Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device
Experimental: QTc Meter - Healthy Controls
Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: iCardiac Technologies, Inc., Minnesota Health Solutions, Blue Ox Healthcare Partners