Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Device: Insertable cardiac monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hypertrophic cardiomyopathy Exclusion Criteria: aortic stenosis (moderate, severe) hypertrophic cardiomyopathy associated with metabolic disease (e.g. Fabry) and syndromes (e.g. Noonan) systolic heart failure cardiac device (previous pacemaker, implantable defibrillator ) history of myocardial infarction percutaneous coronary intervention and/or coronary artery by-pass grafting pulmonary vein isolation, Maze surgery, ventricular tachycardia ablation, ectopic atrial tachycardia ablation renal clearance below 40 malignancy or other comorbidity with less than five years life expectancy pregnancy of planned within 18 months drug addiction, severe mental disease not able to participate in 18 months follow-up 5 years risk more than 6% according HCM risk calculator of European Society of Cardiology guidelines.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insertable cardiac monitor<br>All patients will undergo monitoring using an insertable cardiac monitor (single arm) | Device: Insertable cardiac monitor<br>* Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSVT | Incidence of non-sustained ventricular tachycardia (NSVT) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF | Incidence of atrial fibrillation (AF) | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insertable cardiac monitor, atrial fibrillation, non-sustained ventricular tachycardia