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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Valvular Heart Disease, Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Primary Prevention

Intervention / Treatment
-----------------
* Device: ICD implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Valvular heart disease<br>Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death. | Device: ICD implantation<br>* ICD will be implanted according to current guidelines recommendations.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Appropriate ICD therapy | ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy | Two year after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality was recorded and it will be classified into cardiogenic/non-cardiogenic death. Especially, arrhythmic death was recorded separately. | Two year after study enrollment | 
| Incidence of inappropriate ICD therapy | Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia) | Two year after study enrollment | 
| Type of ventricular arrhythmia | Analyze the type of ventricular arrhythmia | Two year after study enrollment |