Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Device: Extended Cardiac Monitoring

• Registration Number: NCT03182153
• Lead Sponsor: Atlantic Health System

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27
• Primary Completion: 2018-12-28
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled subjects	Extended Cardiac Monitoring	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States