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

NCT04441892 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-07-25

Study results available
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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

Interventions

DEVICE

QTc Meter

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.

Sponsors & Collaborators

  • Blue Ox Healthcare Partners

    collaborator INDUSTRY

  • Minnesota Health Solutions

    collaborator INDUSTRY

  • iCardiac Technologies, Inc.

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michael Ackerman, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2020-03-26
Completion
2020-03-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04441892 on ClinicalTrials.gov