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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2021-07-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Valvular Heart Disease Implantable Cardioverter Defibrillator Sudden Cardiac Death Primary Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Valvular heart disease

Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death.

ICD implantation

Intervention Type DEVICE

ICD will be implanted according to current guidelines recommendations.

Interventions

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ICD implantation

ICD will be implanted according to current guidelines recommendations.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No