Extended ECG Monitoring in HCM Patients

Atrial Fibrillation Clinical Trial

— EXAMINE-HCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056715
• Other study ID #: iRT-001-2019
• Status: Completed
• Start date: January 14, 2020
• Est. completion date: April 18, 2022

Study information

• Verified date: February 2023
• Source: iRhythm Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Nonsustained Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Zio XT
ambulatory cardiac monitoring device

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
iRhythm Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of nsVT runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.	Compare the number of nsVT runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.	14 days
Secondary	Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.	Compare the number of AF runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.	14 days
Secondary	Number of clinical management decisions based on 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours ambulatory cardiac monitoring.	Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring.	14 days