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Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy (ElucidateHcm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259113
Recruitment Status : Unknown
Verified August 2017 by Peter Magnusson, Region Gävleborg.
Recruitment status was:  Recruiting
First Posted : August 23, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
Abbott Medical Devices
Norrlands University Hospital
Information provided by (Responsible Party):
Peter Magnusson, Region Gävleborg

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 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.

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Device: Insertable cardiac monitor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : February 16, 2019
Estimated Study Completion Date : April 16, 2019


Arm Intervention/treatment
Insertable cardiac monitor
All patients will undergo monitoring using an insertable cardiac monitor (single arm)
Device: Insertable cardiac monitor
Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.




Primary Outcome Measures :
  1. NSVT [ Time Frame: 18 months ]
    Incidence of non-sustained ventricular tachycardia (NSVT)


Secondary Outcome Measures :
  1. AF [ Time Frame: 18 months ]
    Incidence of atrial fibrillation (AF)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259113


Contacts
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Contact: Peter Magnusson, MD +46705089407 peter.magnusson@regiongavleborg.se
Contact: Stellan Mörner, MD PhD +46730591068 stellan.morner@umu.se

Locations
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Sweden
Region Gavleborg Recruiting
Gävle, Sweden, 80324
Contact: Peter Magnusson, M.D.    +46705089407    peter.magnusson@regiongavleborg.se   
Contact: Stellan Mörner, M.D. Ph.D    +46730591068    stellan.morner@regiongavleborg.se   
Sponsors and Collaborators
Region Gävleborg
Abbott Medical Devices
Norrlands University Hospital
Investigators
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Principal Investigator: Stellan Mörner, MD PhD Norrlands Universitetssjukhus
Principal Investigator: Peter Magnusson, MD Region Gävleborg
Publications:
American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons, Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1303-38. doi: 10.1016/j.jtcvs.2011.10.019.

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Responsible Party: Peter Magnusson, MD, Region Gävleborg
ClinicalTrials.gov Identifier: NCT03259113    
Other Study ID Numbers: 20171331
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Magnusson, Region Gävleborg:
insertable cardiac monitor
atrial fibrillation
non-sustained ventricular tachycardia
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases