Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

NCT03259113 | Unknown

• 1 other identifier: 20171331
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

insertable cardiac monitor; atrial fibrillation; non-sustained ventricular tachycardia

Outcome Measures

Primary Outcomes (1)

• NSVT

  Incidence of non-sustained ventricular tachycardia (NSVT)

  18 months

Secondary Outcomes (1)

• AF

  18 months

Study Arms (1)

Insertable cardiac monitor

OTHER

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

Device: Insertable cardiac monitor

Interventions

Insertable cardiac monitor DEVICE

Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.

Insertable cardiac monitor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hypertrophic cardiomyopathy

You may not qualify if:

• 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
• years risk more than 6% according HCM risk calculator of European Society of Cardiology guidelines.

Sponsors & Collaborators

• Region Gävleborg: lead
• Abbott Medical Devices: collaborator
• Norrlands University Hospital: collaborator

Study Sites (1)

Region Gavleborg

Gävle, 80324, Sweden

RECRUITING

Related Publications (8)

• 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.

  PMID: 16216855 BACKGROUND

• 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.

  PMID: 12957437 BACKGROUND

• 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.

  PMID: 10952953 BACKGROUND

• 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.

  PMID: 12651046 BACKGROUND

• 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.

  PMID: 10334430 BACKGROUND

• 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.

  PMID: 22093712 BACKGROUND

• 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.

  PMID: 25173338 BACKGROUND

• 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.

  PMID: 33108031 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stellan Mörner, MD PhD

  Norrlands Universitetssjukhus

  PRINCIPAL INVESTIGATOR

• Peter Magnusson, MD

  Region Gävleborg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Magnusson, MD

CONTACT

+46705089407; peter.magnusson@regiongavleborg.se

Stellan Mörner, MD PhD

CONTACT

+46730591068; stellan.morner@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy

Study Record Dates

• First Submitted: August 19, 2017
• First Posted: August 23, 2017
• Study Start: August 16, 2017
• Primary Completion: February 16, 2019
• Study Completion: April 16, 2019
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)