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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03259113
Date of registration:	19/08/2017
Prospective Registration:	No
Primary sponsor:	Region Gävleborg
Public title:	Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy ElucidateHcm
Scientific title:	EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy
Date of first enrolment:	August 16, 2017
Target sample size:	30
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03259113
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Sweden

Contacts

Name:	Peter Magnusson, M.D.
Address:
Telephone:	+46705089407
Email:	peter.magnusson@regiongavleborg.se
Affiliation:

Name:	Peter Magnusson, MD
Address:
Telephone:
Email:
Affiliation:	Region Gävleborg

Name:	Peter Magnusson, MD
Address:
Telephone:	+46705089407
Email:	peter.magnusson@regiongavleborg.se
Affiliation:

Name:	Stellan Mörner, MD PhD
Address:
Telephone:
Email:
Affiliation:	Norrlands Universitetssjukhus

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertrophic Cardiomyopathy

Intervention(s)

Device: Insertable cardiac monitor

Primary Outcome(s)

NSVT [Time Frame: 18 months]

Secondary Outcome(s)

AF [Time Frame: 18 months]

Secondary ID(s)

20171331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Jude Medical

Norrlands University Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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