Hypertrophic Cardiomyopathy
Conditions
Brief summary
Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.
Detailed description
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.
Interventions
Extended External Cardiac Monitoring
Sponsors
Atlantic Health System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk Stratification for sudden death (SD) | Through study completion, an average of 1 year. | 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) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Atrial Fibrillation | Through study completion, an average of 1 year. | 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. |
Countries
United States
Outcome results
None listed