Extended ECG Monitoring in HCM Patients

NCT ID: NCT04056715

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-14

Study Completion Date

2022-04-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertrophic Cardiomyopathy Nonsustained Ventricular Tachycardia Ventricular Tachycardia Atrial Fibrillation Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCM Group

Eligible HCM subjects will be monitored for arrhythmias with a 2-week ECG patch.

Zio XT

Intervention Type DEVICE

ambulatory cardiac monitoring device

Interventions

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Zio XT

ambulatory cardiac monitoring device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iRhythm Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Maron, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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iRT-001-2019

Identifier Type: -

Identifier Source: org_study_id

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