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

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.

Study Overview

• Status: Terminated
• Conditions: Primary Prevention; Valvular Heart Disease; Sudden Cardiac Death; Implantable Cardioverter Defibrillator
• Intervention / Treatment: Device: ICD implantation

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

• Study Contact: Name: Jongmin Hwang, MD, Ph D; Phone Number: +82-053-250-7333; Email: dsmcep@dsmc.or.kr

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of, 21080
    • Mediplex Sejong Hospital
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 05505
    • Seoul ASAN Medical Center
  • Seoul, Korea, Republic of, 06591
    • Seoul st. mary's hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Cardiovascular Hospital
  • Seoul, Korea, Republic of, 06351
    • Seoul Samsung Medical Center
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• South Korean patients visiting the one of the investigator's study participating hospital will be enrolled.
• Valvular cardiomyopathy patients with left ventricular ejection fraction ≤ 35% with symptoms of NYHA class II, III despite optimal medical treatment for more than 3 months according to the guideline recommendations for heart failure treatment and are expected to survive for more than one year.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Valvular heart disease; Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death.	Device: ICD implantation; ICD will be implanted according to current guidelines recommendations.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of inappropriate ICD therapy	Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia)	Two year after study enrollment
Type of ventricular arrhythmia	Analyze the type of ventricular arrhythmia	Two year after study enrollment

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Seongwook Han, MD, Ph D, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Heart Diseases; Death; Cardiomyopathies; Heart Valve Diseases; Death, Sudden, Cardiac
• Other Study ID Numbers: 2017-08-027-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No