Extended ECG Monitoring in HCM Patients

NCT04056715 | Completed FDA Device

• 1 other identifier: iRT-001-2019
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

electrocardiography; electrocardiogram; mobile cardiac monitoring; ambulatory monitoring; ECG; EKG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours.

  14 days

• 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

Study Arms (1)

HCM Group

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

Device: Zio XT

Interventions

Zio XT DEVICE

ambulatory cardiac monitoring device

HCM Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from the hypertrophic cardiomyopathy population will be recruited.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iRhythm Technologies, Inc.: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Tachycardia, Ventricular; Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Tachycardia; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Maron, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: January 14, 2020
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)