Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.

Detailed Description
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Eligible subjects will be monitored with a SEEQ device. The SEEQ device is a patch-like device that is worn externally on the chest and continuously monitors heart rhythm. Each device is worn for seven days and replaced with additional devices for a total of 28 days of monitoring. Subjects will return the SEEQ equipment at the end of the monitoring period. Subjects will be contacted by telephone or seen at the clinic approximately 60 days from the first day of monitoring. Information will be gathered about medications and any cardiac interventions the subject may have had. Subjects will again be contacted by telephone or seen in the clinic approximately 1 year from study start. Information will be gathered about general health, changes in medications, and cardiac interventions or events. Cardiac testing results will be reviewed.

Official Title
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Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Device: Extended Cardiac Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center Exclusion Criteria: Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled subjects<br>Subjects who are diagnosed with HCM and require routine extended cardiac monitoring for risk stratification of sudden cardiac death. All subjects will receive 28 days of external cardiac monitoring. | Device: Extended Cardiac Monitoring<br>* Extended External Cardiac Monitoring<br>* Other names: Medtronic SEEQ™ Mobile Cardiac Telemetry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Stratification for sudden death (SD) | We aim to determine if longer term monitoring (28 days) with the Medtronic SEEQ MCT device identifies a greater burden of non-sustained ventricular tachycardia (NSVT) compared to conventional shorter monitoring periods (48 hours), and thereby potentially identify a subset of HCM patients who may be at higher risk of SD and benefit from a primary prevention implantable cardioverter-defibrillator (ICD) . | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Atrial Fibrillation | To determine if longer term monitoring (28 days) with the Medtronic SEEQ MCT device identifies a greater burden of symptomatic (or asymptomatic) atrial fibrillation compared to conventional shorter monitoring periods (48 hours), and thereby identify a subset of HCM patients who may be at higher risk of symptom progression and stroke. | Through study completion, an average of 1 year. |