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Extended ECG Monitoring in HCM Patients (EXAMINE-HCM)

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ClinicalTrials.gov Identifier: NCT04056715
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : September 8, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2022


Group/Cohort 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




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


Secondary Outcome Measures :
  1. Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. [ Time Frame: 14 days ]
    Compare the number of AF runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.

  2. Number of clinical management decisions based on 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours ambulatory cardiac monitoring. [ Time Frame: 14 days ]
    Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from the hypertrophic cardiomyopathy population will be recruited.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056715


Contacts
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Contact: Daniel Higgins 617-636-4928 dhiggins@tuftsmedicalcenter.org
Contact: Gaurav Das 617-636-4928 gdas@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact: Martin Maron, MD         
Sponsors and Collaborators
iRhythm Technologies, Inc.
Investigators
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Principal Investigator: Martin Maron, MD Tufts Medical Center

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Responsible Party: iRhythm Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04056715     History of Changes
Other Study ID Numbers: iRT-001-2019
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by iRhythm Technologies, Inc.:
electrocardiography
electrocardiogram
mobile cardiac monitoring
ambulatory monitoring
ECG
EKG
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Atrial Fibrillation
Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases