CClinicalTrials.gg
Status unknownNCT03182153Updated Jun 27, 2018

Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

An observational study in Hypertrophic Cardiomyopathy, sponsored by Atlantic Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Atlantic Health System · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
83
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 83 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Atlantic Health System is the lead sponsor of 61 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any HCM patient followed in the Chanin T. Mast HCM Center at Morristown Medical Center, Morristown, NJ, who is prescribed holter monitoring for risk stratification for SD.

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

Exclusion Criteria:

Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
83 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Extended Cardiac Monitoring

Interventions

  • DeviceExtended Cardiac Monitoring

    Extended External Cardiac Monitoring

    Also known as: Medtronic SEEQ™ Mobile Cardiac Telemetry

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

07

Study locations

1 site
  • Morristown Medical Center
    Morristown, New Jersey 07960, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03182153
Lead sponsor
Atlantic Health System
Responsible party
Sponsor
First posted
Jun 9, 2017
Start date
Nov 2016
Primary completion
Dec 28, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jun 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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