Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care

NCT04441892 | Terminated Results FDA Device

• 1 other identifier: 18-006014
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 primary care environment.

Conditions

Long QT Syndrome

Outcome Measures

Primary Outcomes (1)

• Low Cost QTc Meter for Long QT Syndrome Screening

  Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5

  Baseline

Study Arms (2)

QTc Meter

EXPERIMENTAL

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

Device: QTc Meter

QTc Meter - Healthy Controls

EXPERIMENTAL

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.

Device: QTc Meter

Interventions

QTc Meter DEVICE

Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.

QTc Meter; QTc Meter - Healthy Controls

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants (Day 0 - 5 years).
• Long QT Syndrome(LQTS).
• Newborns without LQTS (Controls).
• Parental willingness to provide informed consent and follow the study protocol.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• Blue Ox Healthcare Partners: collaborator
• Minnesota Health Solutions: collaborator
• iCardiac Technologies, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Long QT Syndrome

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

Limitations and Caveats

Last patient enrolled in February of 2020. Enrollment was paused because of stay-at-home COVID mandates and even when general clinical operations resumed, elective clinical studies like these were not immediately resumed in the ECG monitoring lab to limit the number of people around patients. By the time recruitment could resume, the collaborating company had run out of funding for the study and the study was terminated. Study only enrolled 33 participates out of anticipated 1050.

Results Point of Contact

• Title: Dr. Michael J. Ackerman
• Organization: Mayo Clinic

ackerman.michael@mayo.edu

507-284-8900

Study Officials

• Michael Ackerman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: February 7, 2019
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-07

Locations

US (1)