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OpenTrials
Completed

NCT Number: NCT04056715

Extended ECG Monitoring in HCM Patients

The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc. Zio XT device results in identifying a greater burden of nonsustained ventricular tachyarrhythmia (nsVT) compared to current ACCF/AHA guideline recommended 48-hour monitoring.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Nonsustained Ventricular Tachycardia Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

Optimal duration to monitor patients for identifying nsVT remains unclear. The investigators aim to determine the prevalence and burden of nsVT with longer term monitoring with the iRhythm Zio XT device over a 2-week period vs. 48 hours; and whether, this greater burden of nsVT compared to conventional shorter monitoring potentially identifies a subset of HCM patients who may be at higher risk of sudden cardiac death.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be 18 to 65 years of age at time of informed consent and must not be a member of a vulnerable population.
  • Subject has been diagnosed with hypertrophic cardiomyopathy, as defined by a maximal LV wall thickness of ≥15 mm anywhere in LV wall, in absence of another cause that could be responsible for the LV hypertrophy.
  • Subject eligible to receive the Zio XT device per the current approved indications for use.

Exclusion criteria

  • Subject with pacemaker
  • Known skin allergies or reaction to adhesives
  • The investigator deems a condition that could limit a subject's ability or unwillingness to participate in the study, comply with study required monitoring and/or follow-up visits.

Treatment and study plan

Zio XT

Device

ambulatory cardiac monitoring device

Primary outcomes

  1. Total number of nsVT runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.

    Time frame: 14 days

    Compare the number of nsVT runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.

Secondary outcomes

  1. Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.

    Time frame: 14 days

    Compare the number of AF runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.

  2. Number of clinical management decisions based on 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours ambulatory cardiac monitoring.

    Time frame: 14 days

    Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring.

Sponsors and collaborators

Lead sponsor

iRhythm Technologies, Inc.

Industry

Registry information

Official study title

Extended Ambulatory Monitoring With iRhythm Zio XT Improves Care of Patients With Hypertrophic Cardiomyopathy

Acronym: EXAMINE-HCM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2019
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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