Extended ECG Monitoring in HCM Patients

Completed

• Conditions: Nonsustained Ventricular Tachycardia; Atrial Fibrillation; Arrhythmia; Hypertrophic Cardiomyopathy; Ventricular Tachycardia
• Interventions: Device: Zio XT

• Registration Number: NCT04056715
• Lead Sponsor: iRhythm Technologies, Inc.

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.

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 Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-14
• Study Start: 2020-01-14
• Primary Completion: 2022-04-18
• Study Completion: 2022-04-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCM Group	Zio XT	Eligible HCM subjects will be monitored for arrhythmias with a 2-week ECG patch.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States