Status:
COMPLETED
Extended ECG Monitoring in HCM Patients
Lead Sponsor:
iRhythm Technologies, Inc.
Conditions:
Hypertrophic Cardiomyopathy
Nonsustained Ventricular Tachycardia
Eligibility:
All Genders
18-65 years
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...
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 devi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 18 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04056715
Start Date
January 14 2020
End Date
April 18 2022
Last Update
March 1 2023
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111