NCT04056715

Extended ECG Monitoring in HCM Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: iRhythm Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertrophic Cardiomyopathy
• Nonsustained Ventricular Tachycardia
• Ventricular Tachycardia
• Atrial Fibrillation
• Arrhythmia

Interventions

Type	Name	Description
DEVICE	Zio XT	ambulatory cardiac monitoring device

Timeline

• Start date: 2020-01-14
• Primary completion: 2022-04-18
• Completion: 2022-04-18
• First posted: 2019-08-14
• Last updated: 2023-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study