NCT03259113

Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Region Gävleborg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Detection of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF) using an insertable cardiac device monitor (SJM Confirm XT) which is connected to the patients smart phone and monitored for 18 months.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	Insertable cardiac monitor	Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.

Timeline

• Start date: 2017-08-16
• Primary completion: 2019-02-16
• Completion: 2019-04-16
• First posted: 2017-08-23
• Last updated: 2017-08-25

Locations

1 site across 1 country: Sweden