Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy (ElucidateHcm)

August 24, 2017 updated by: Peter Magnusson, Region Gävleborg

EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Gävleborg

Collaborators

Abbott Medical Devices
Norrlands University Hospital

Investigators

  • Principal Investigator: Stellan Mörner, MD PhD, Norrlands Universitetssjukhus
  • Principal Investigator: Peter Magnusson, MD, Region Gävleborg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2017

Primary Completion (Anticipated)

February 16, 2019

Study Completion (Anticipated)

April 16, 2019

Study Registration Dates

First Submitted

August 19, 2017

First Submitted That Met QC Criteria

August 19, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20171331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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