An observational study in Valvular Heart Disease, Implantable Cardioverter Defibrillator and Sudden Cardiac Death, sponsored by Keimyung University Dongsan Medical Center. Terminated at 12 sites in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Keimyung University Dongsan Medical Center · Observational
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.
3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 12 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.
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Patients who meet one of the following criteria:
Patients without evidence of ischemic heart disease (who meet one of the following criteria):
epicardial coronary stenosis \<70%, left main stenosis \<50%
Exclusion Criteria:
Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death.
Device: ICD implantation
ICD will be implanted according to current guidelines recommendations.
Incidence of Appropriate ICD therapy
ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy
Time frame: Two year after study enrollment
Mortality
mortality was recorded and it will be classified into cardiogenic/non-cardiogenic death. Especially, arrhythmic death was recorded separately.
Time frame: Two year after study enrollment
Incidence of inappropriate ICD therapy
Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia)
Time frame: Two year after study enrollment
Type of ventricular arrhythmia
Analyze the type of ventricular arrhythmia
Time frame: Two year after study enrollment
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Keimyung University Dongsan Medical Center