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The trial stopped prematurely because of enrollment challenges.
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valvular heart disease | Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD implantation | Device | ICD will be implanted according to current guidelines recommendations. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patients who meet one of the following criteria:
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):
epicardial coronary stenosis <70%, left main stenosis <50%
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seongwook Han, MD, Ph D | Keimyung University Dongsan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea | ||
| Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.
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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 |
| Daegu |
| 41944 |
| South Korea |
| Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital | Daegu | 42415 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Mediplex Sejong Hospital | Incheon | 21080 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Cardiovascular Hospital | Seoul | 03722 | South Korea |
| Seoul Asan Medical Center | Seoul | 05505 | South Korea |
| Seoul Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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