Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy

  • STATUS
    Recruiting
  • End date
    Nov 15, 2021
  • participants needed
    122
  • sponsor
    Keimyung University Dongsan Medical Center
Updated on 24 January 2021
stenosis
ejection fraction
heart failure
heart disease
cardiomyopathy
implantable cardioverter-defibrillators
valvular disease
mitral valve disease
rheumatic heart disease

Summary

The prevalence of valvular heart disease is on the rise along with the aging society and the generalization of echocardiography. Furthermore, the rheumatic valvular heart disease is much more prevalent in Asia than in Western countries, and the frequency of valve disease is higher in Asia. The effect of an implantable cardioverter defibrillator (ICD) in the primary prevention of sudden cardiac death in ischemic cardiomyopathy is well established and has become a standard of care. However, there is limited research on the effect of ICD implantation for primary prevention in patients with heart failure due to valvular heart disease. In a small study, the incidence of fatal cardiac arrhythmia was lower in patients with valvular cardiomyopathy (5%) who received ICD implantation for primary prevention than in those with ischemic cardiomyopathy. But there is also a report that the appropriate ICD treatment is not different from that of ischemic heart disease in valvular heart disease patients. Therefore, it is necessary to study the primary prevention effect of ICD on valvular cardiomyopathy in a larger number of patients. The purpose of this study was to investigate the effect of ICD on the prevention of sudden cardiac death in patients with heart failure due to valvular heart disease through prospective, multicenter, and observational studies.

Details
Condition Implantable defibrillator, Sudden Cardiac Death, Heart disease, VALVULAR HEART DISEASE, Primary Prevention, Heart Valve Disease, Cardiac Disease, implantable cardioverter-defibrillators, implantable cardioverter defibrillator
Treatment ICD implantation
Clinical Study IdentifierNCT03590730
SponsorKeimyung University Dongsan Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 19 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Implantable defibrillator or Heart Valve Disease or VALVULAR HEART DISEASE or Sudden Cardiac Death or Cardiac Disease or Primary Prevention or Heart d...?
Do you have any of these conditions: implantable cardioverter-defibrillators or Primary Prevention or Sudden Cardiac Death or implantable cardioverter defibrillator or VALVULAR HEART DISE...?
Patients who meet one of the following criteria
Patients who have undergone surgery for aortic valve or mitral valve disease for more than 12 months
Patients with severe aortic valve or mitral valve disease
Patients with left ventricular ejection fraction 35% by echocardiography or other imaging methods
US, European practice guidelines class I indication for ICD implantation
Patients without evidence of ischemic heart disease (who meet one of the following criteria)
Stress test negative
Significant stenosis was not observed in coronary artery images
epicardial coronary stenosis <70%, left main stenosis <50%
History of heart failure symptoms
Patients who have received medication for more than 3 months according to the heart failure treatment guideline recommendation

Exclusion Criteria

Patients with left ventricular dysfunction without valvular heart disease
Patients who require cardiac pacing therapy due to bradycardia
Heart transplant scheduled
Life expectancy is less than one year
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