Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-12-31

Brief Summary

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

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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.

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Enrolled subjects

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.

Extended Cardiac Monitoring

Intervention Type DEVICE

Extended External Cardiac Monitoring

Interventions

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Extended Cardiac Monitoring

Extended External Cardiac Monitoring

Intervention Type DEVICE

Other Intervention Names

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Medtronic SEEQ™ Mobile Cardiac Telemetry

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