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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03590730
Other study ID # 2017-08-027-007
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 15, 2017
Est. completion date July 15, 2021

Study information

Verified date May 2023
Source Keimyung University Dongsan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date July 15, 2021
Est. primary completion date July 10, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Study Design


Intervention

Device:
ICD implantation
ICD will be implanted according to current guidelines recommendations.

Locations

Country Name City State
Korea, Republic of Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital Daegu
Korea, Republic of Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital Daegu
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Mediplex Sejong Hospital Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Seoul Asan Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul Samsung Medical Center Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul
Korea, Republic of Severance Cardiovascular Hospital Seoul
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do

Sponsors (2)

Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Appropriate ICD therapy ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy Two year after study enrollment
Secondary 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
Secondary Incidence of inappropriate ICD therapy Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia) Two year after study enrollment
Secondary Type of ventricular arrhythmia Analyze the type of ventricular arrhythmia Two year after study enrollment
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