EXAMINE-HCM: Extended ECG Monitoring in HCM Patients

Sponsor

iRhythm Technologies, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04056715

Collaborator

(none)

300

Enrollment

Location

24.6

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy Nonsustained Ventricular Tachycardia Ventricular Tachycardia Atrial Fibrillation Arrhythmia	Device: Zio XT

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 14, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
HCM Group Eligible HCM subjects will be monitored for arrhythmias with a 2-week ECG patch.	Device: Zio XT ambulatory cardiac monitoring device

Arm

Intervention/Treatment

HCM Group

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

Device: Zio XT

ambulatory cardiac monitoring device

Outcome Measures

Primary Outcome Measures

Total number of nsVT runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. [14 days]
Compare the number of nsVT runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.

Secondary Outcome Measures

Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. [14 days]
Compare the number of AF runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.
Number of clinical management decisions based on 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours ambulatory cardiac monitoring. [14 days]
Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.