Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

Atlantic Health System83 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypertrophic Cardiomyopathy

Interventions

Extended Cardiac MonitoringDEVICE

Extended External Cardiac Monitoring

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Morristown Medical Center

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

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) .

Time frame: Through study completion, an average of 1 year.

Secondary Outcomes

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.

Time frame: Through study completion, an average of 1 year.

Data from ClinicalTrials.gov

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