An observational study in Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia and Ventricular Tachycardia, sponsored by iRhythm Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by iRhythm Technologies, Inc. · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 250 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →iRhythm Technologies, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from the hypertrophic cardiomyopathy population will be recruited.
Exclusion Criteria:
Eligible HCM subjects will be monitored for arrhythmias with a 2-week ECG patch.
Device: Zio XT
ambulatory cardiac monitoring device
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.
Time frame: 14 days
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.
Time frame: 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.
Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring.
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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iRhythm Technologies, Inc.