MedTrace Logo

Validation of an iPhone-based Event Recorder for Arrhythmia Detection

NCT02005172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-05-25

Study results available
· View outcomes & findings →

Summary

In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device.

Hypothesis:

1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms.
2. The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.

Conditions

  • Arrhythmia, Palpitations, Lightheadedness

Interventions

DEVICE

Alivecor monitor and 14 day event monitor

Alivecor monitor and 14 day event monitor

Sponsors & Collaborators

  • University at Buffalo

    lead OTHER

Principal Investigators

  • Anne Curtis, MD · University at Buffalo

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-03-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02005172 on ClinicalTrials.gov