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

Sudden Cardiac Death Clinical Trial

— BEAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03590730
• Other study ID #: 2017-08-027-007
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Death
• Death, Sudden, Cardiac
• Heart Diseases
• Heart Valve Diseases
• Implantable Cardioverter Defibrillator
• Primary Prevention
• Sudden Cardiac Death
• Valvular Heart Disease

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