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Status unknownNCT03259113ElucidateHcmUpdated Aug 25, 2017

Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

An interventional study of Insertable cardiac monitor in Hypertrophic Cardiomyopathy, sponsored by Region Gävleborg. Status unknown at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by Region Gävleborg · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertrophic Cardiomyopathy

Keywords

  • insertable cardiac monitor
  • atrial fibrillation
  • non-sustained ventricular tachycardia
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • hypertrophic cardiomyopathy

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Insertable cardiac monitor

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

    Device: Insertable cardiac monitor

Interventions

  • DeviceInsertable cardiac monitor

    Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.

05

What researchers measure

Primary outcomes

  1. NSVT

    Incidence of non-sustained ventricular tachycardia (NSVT)

    Time frame: 18 months

Secondary outcomes

  1. AF

    Incidence of atrial fibrillation (AF)

    Time frame: 18 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • 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. PubMed 16216855 ↗
  • 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. PubMed 12957437 ↗
  • 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. PubMed 10952953 ↗
  • 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. PubMed 12651046 ↗
  • 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. PubMed 10334430 ↗
  • 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. PubMed 22093712 ↗
  • 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. PubMed 25173338 ↗
  • 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. PubMed 33108031 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03259113
Lead sponsor
Region Gävleborg
Collaborators
Abbott Medical Devices, Norrlands University Hospital
Responsible party
Peter Magnusson (MD, Region Gävleborg) — Principal investigator
First posted
Aug 23, 2017
Start date
Aug 16, 2017
Primary completion
Feb 16, 2019 (estimated)
Completion
Apr 16, 2019 (estimated)
Last update
Aug 25, 2017

Study contacts

Peter Magnusson, MD
Contact
peter.magnusson@regiongavleborg.se
+46705089407
Stellan Mörner, MD PhD
Contact
stellan.morner@umu.se
+46730591068
Stellan Mörner, MD PhD
principal investigator · Norrlands Universitetssjukhus
Peter Magnusson, MD
principal investigator · Region Gävleborg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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