Arrhythmia, Atrial Fibrillation, Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia, Ventricular Tachycardia
Conditions
Keywords
electrocardiography, electrocardiogram, mobile cardiac monitoring, ambulatory monitoring, ECG, EKG
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.
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.
Interventions
DEVICEZio XT
ambulatory cardiac monitoring device
Sponsors
iRhythm Technologies, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of nsVT runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. | 14 days | Compare the number of nsVT runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. | 14 days | Compare the number of AF runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring. |
| 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 | Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring. |
Countries
United States
Outcome results
None listed