search
Back to results

Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy (ElucidateHcm)

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Insertable cardiac monitor
Sponsored by
Region Gävleborg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertrophic Cardiomyopathy focused on measuring insertable cardiac monitor, atrial fibrillation, non-sustained ventricular tachycardia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Region GavleborgRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Insertable cardiac monitor

Arm Description

All patients will undergo monitoring using an insertable cardiac monitor (single arm)

Outcomes

Primary Outcome Measures

NSVT
Incidence of non-sustained ventricular tachycardia (NSVT)

Secondary Outcome Measures

AF
Incidence of atrial fibrillation (AF)

Full Information

First Posted
August 19, 2017
Last Updated
August 24, 2017
Sponsor
Region Gävleborg
Collaborators
Abbott Medical Devices, Norrlands University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03259113
Brief Title
Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy
Acronym
ElucidateHcm
Official Title
EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
February 16, 2019 (Anticipated)
Study Completion Date
April 16, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Gävleborg
Collaborators
Abbott Medical Devices, Norrlands University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
insertable cardiac monitor, atrial fibrillation, non-sustained ventricular tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insertable cardiac monitor
Arm Type
Other
Arm Description
All patients will undergo monitoring using an insertable cardiac monitor (single arm)
Intervention Type
Device
Intervention Name(s)
Insertable cardiac monitor
Intervention Description
Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.
Primary Outcome Measure Information:
Title
NSVT
Description
Incidence of non-sustained ventricular tachycardia (NSVT)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
AF
Description
Incidence of atrial fibrillation (AF)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Magnusson, MD
Phone
+46705089407
Email
peter.magnusson@regiongavleborg.se
First Name & Middle Initial & Last Name or Official Title & Degree
Stellan Mörner, MD PhD
Phone
+46730591068
Email
stellan.morner@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stellan Mörner, MD PhD
Organizational Affiliation
Norrlands Universitetssjukhus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Magnusson, MD
Organizational Affiliation
Region Gävleborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Gavleborg
City
Gävle
ZIP/Postal Code
80324
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Magnusson, M.D.
Phone
+46705089407
Email
peter.magnusson@regiongavleborg.se
First Name & Middle Initial & Last Name & Degree
Stellan Mörner, M.D. Ph.D
Phone
+46730591068
Email
stellan.morner@regiongavleborg.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16216855
Citation
Elliott PM, Gimeno JR, Thaman R, Shah J, Ward D, Dickie S, Tome Esteban MT, McKenna WJ. Historical trends in reported survival rates in patients with hypertrophic cardiomyopathy. Heart. 2006 Jun;92(6):785-91. doi: 10.1136/hrt.2005.068577. Epub 2005 Oct 10.
Results Reference
background
PubMed Identifier
12957437
Citation
Maron BJ, Casey SA, Hauser RG, Aeppli DM. Clinical course of hypertrophic cardiomyopathy with survival to advanced age. J Am Coll Cardiol. 2003 Sep 3;42(5):882-8. doi: 10.1016/s0735-1097(03)00855-6.
Results Reference
background
PubMed Identifier
10952953
Citation
Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.
Results Reference
background
PubMed Identifier
12651046
Citation
Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.
Results Reference
background
PubMed Identifier
10334430
Citation
Elliott PM, Sharma S, Varnava A, Poloniecki J, Rowland E, McKenna WJ. Survival after cardiac arrest or sustained ventricular tachycardia in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 1999 May;33(6):1596-601. doi: 10.1016/s0735-1097(99)00056-x.
Results Reference
background
PubMed Identifier
22093712
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
25173338
Citation
Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
Results Reference
background
PubMed Identifier
33108031
Citation
Magnusson P, Morner S. EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic Cardiomyopathy (ELUCIDATE HCM): A prospective observational study on incidence of arrhythmias. J Cardiovasc Electrophysiol. 2021 Jan;32(1):129-135. doi: 10.1111/jce.14792. Epub 2020 Nov 4.
Results Reference
derived

Learn more about this trial

Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

We'll reach out to this number within 24 hrs