Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

Region Gävleborg30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hypertrophic Cardiomyopathy

Interventions

Insertable cardiac monitorDEVICE

Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Region Gavleborg

Gävle, Sweden

RECRUITING

Outcomes

Primary Outcomes

NSVT

Incidence of non-sustained ventricular tachycardia (NSVT)

Time frame: 18 months

Secondary Outcomes

Incidence of atrial fibrillation (AF)

Time frame: 18 months

Central Contacts

Peter Magnusson, MD

CONTACT

+46705089407 peter.magnusson@regiongavleborg.se

Stellan Mörner, MD PhD

CONTACT

+46730591068 stellan.morner@umu.se

Data from ClinicalTrials.gov

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