Health TrialsbyHealthPanel

Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan

ConditionsAtrial Fibrillation (AF)Atrial FlutterSupraventricular Tachycardia (SVT)Ventricular Tachycardia (VT)Ventricular FibrillationAtrioventricular Block, Second and Third DegreeComplete Heart BlockArrhythmias CardiacCardiac PauseSyncope and CollapseDizzynessFaintingBradycardiaSinus Bradycardia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsoriRhythm Technologies, Inc.

About this trial

The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is 18 years of age and older

Participant has reported symptoms that would prompt ambulatory ECG monitoring (i.e. palpitations, dizziness or lightheadedness, syncope or presyncope, shortness of breath, or asymptomatic)

Participant is prescribed Heartnote device as part of clinical care

Participant is willing and able to provide informed consent and able to complete all visits for this study

Disqualifiers

Participant has known permanent or persistent (i.e., 100% burden) atrial fibrillation (AF)

Participants in whom inpatient monitoring should be prescribed.

Participant has a known allergy to adhesives.

Participant has a current skin infection or injury at location for study device placement.

Trial design

Design model

Single group

Treatments tested in this trial

  • Application of ambulatory cardiac monitor

    Diagnostic test

    Application of a second ambulatory cardiac monitor to be worn simultaneously with the standard of care monitor.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Simultaneous wear of ECG patchesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinically actionable arrhythmias through the end of indicated wear duration

Yield of clinically actionable arrhythmias through the end of indicated wear duration for Zio monitor and Heartnote patch ECG.

Time frame
Enrollment through day 14

Secondary outcomes

1

Clinically actionable arrhythmias through 7 days

Clinically actionable arrhythmias through 7 days of wear for Zio monitor and Heartnote patch ECG.

Time frame
Enrollment through day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

iRhythm Technologies, Inc.

Lead sponsor

A2 Healthcare Taiwan Corporation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: