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

NCT03590730 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-10-19

No results posted yet for this study

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.

Conditions

  • Valvular Heart Disease
  • Implantable Cardioverter Defibrillator
  • Sudden Cardiac Death
  • Primary Prevention

Interventions

DEVICE

ICD implantation

ICD will be implanted according to current guidelines recommendations.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Keimyung University Dongsan Medical Center

    lead OTHER

Principal Investigators

  • Seongwook Han, MD, Ph D · Keimyung University Dongsan Medical Center

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-07-10
Completion
2021-07-15

Countries

  • South Korea

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03590730 on ClinicalTrials.gov