Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

— ElucidateHcm  

Official title:

EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259113
• Other study ID #: 20171331
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2017
• Last updated: August 24, 2017
• Start date: August 16, 2017
• Est. completion date: April 16, 2019

Study information

• Verified date: August 2017
• Source: Region Gävleborg
• Contact: Peter Magnusson, MD
• Phone: +46705089407
• Email: peter.magnusson[@]regiongavleborg.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 16, 2019
• Est. primary completion date: February 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Device:
• Insertable cardiac monitor
Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.

Locations

Country	Name	City	State
Sweden	Region Gavleborg	Gävle

Sponsors (3)

Lead Sponsor	Collaborator
Region Gävleborg	Norrlands University Hospital, St. Jude Medical

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

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. — View 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. — View 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. Epub 2005 Oct 10. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NSVT	Incidence of non-sustained ventricular tachycardia (NSVT)	18 months
Secondary	AF	Incidence of atrial fibrillation (AF)	18 months