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

Keimyung University

Status: Terminated

Conditions: Valvular Heart Disease; Primary Prevention; Sudden Cardiac Death; Implantable Cardioverter Defibrillator

Treatments: Device: ICD implantation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03590730

2017-08-027-007

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Valvular heart disease

Description:

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

Treatment:

Device: ICD implantation