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

Terminated

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

• Registration Number: NCT03590730
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-18
• Primary Completion: 2019-07-10
• Study Completion: 2021-07-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Appropriate ICD therapy	Two year after study enrollment	ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy

Secondary Outcome Measures

Name	Time	Method
Mortality	Two year after study enrollment	mortality was recorded and it will be classified into cardiogenic/non-cardiogenic death. Especially, arrhythmic death was recorded separately.
Incidence of inappropriate ICD therapy	Two year after study enrollment	Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia)
Type of ventricular arrhythmia	Two year after study enrollment	Analyze the type of ventricular arrhythmia

Trial Locations

Locations (12)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangnam-do, 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 National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Cardiovascular Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

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