Status:
UNKNOWN
Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy
Lead Sponsor:
Region Gävleborg
Collaborating Sponsors:
Abbott Medical Devices
Norrlands University Hospital
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
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 mo...
Eligibility Criteria
Inclusion
- hypertrophic cardiomyopathy
Exclusion
- 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.
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 16 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03259113
Start Date
August 16 2017
End Date
April 16 2019
Last Update
August 25 2017
Active Locations (1)
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1
Region Gavleborg
Gävle, Sweden, 80324