Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy

NCT03182153 | Unknown FDA Device

• 1 other identifier: SEEQ
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

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) .

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• Detection of Atrial Fibrillation

  Through study completion, an average of 1 year.

Study Arms (1)

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

Extended Cardiac Monitoring DEVICE

Extended External Cardiac Monitoring

Also known as: Medtronic SEEQ™ Mobile Cardiac Telemetry

Enrolled subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center

You may not qualify if:

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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 9, 2017
• Study Start: November 1, 2016
• Primary Completion: December 28, 2018
• Study Completion: December 31, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)