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Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

NCT03259113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-25

No results posted yet for this study

Summary

Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will provide data on cardiac rhythm over a period of 18 months. This will provide an extended monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care. Therefore, detection of arrhythmias could be used in risk stratification and decision-making with regard to offer an implantable defibrillator and anticoagulants.

Conditions

Interventions

DEVICE

Insertable cardiac monitor

Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Norrlands University Hospital

    collaborator OTHER

  • Region Gävleborg

    lead OTHER

Principal Investigators

  • Stellan Mörner, MD PhD · Norrlands Universitetssjukhus

  • Peter Magnusson, MD · Region Gävleborg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2019-02-16
Completion
2019-04-16

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259113 on ClinicalTrials.gov