NCT03182153

Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Atlantic Health System · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	Extended Cardiac Monitoring	Extended External Cardiac Monitoring

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-12-28
• Completion: 2018-12-31
• First posted: 2017-06-09
• Last updated: 2018-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study