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Benefits of ICD for the primary prEvention in patients with vAlvular cardiomyopathy

Status Approved

  • First Submitted Date

    2019/02/13

  • Registered Date

    2019/08/21

  • Last Updated Date

    2021/11/11

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0004228
    Unique Protocol ID 2017-08-027
    Public/Brief Title Benefits of ICD in patients with valvular cardiomyopathy
    Scientific Title Benefits of ICD for the primary prEvention in patients with vAlvular cardiomyopathy
    Acronym BEAT
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT03590730
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DSMC 2017-08-027-001
    Approval Date 2017-11-20
    Institutional Review Board Name Keimyung University Dongsan Medical Center Institutional Review Board
    Institutional Review Board Address 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Republic of Korea
    Institutional Review Board Telephone 053-258-6694
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Seongwook Han
    Title Professor
    Telephone +82-53-258-7717
    Affiliation Keimyung University Dongsan Hospital
    Address 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Republic of Korea
    Contact Person for Public Queries
    Name Seongwook Han
    Title Professor
    Telephone +82-53-258-7717
    Affiliation Keimyung University Dongsan Hospital
    Address 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Republic of Korea
    Contact Person for Updating Information
    Name Seongwook Han
    Title Professor
    Telephone +82-53-258-7717
    Affiliation Keimyung University Dongsan Hospital
    Address 1035, Dalgubeol-daero, Dalseo-gu, Daegu, 42601, Republic of Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 13
    Overall Recruitment Status Active, not recruiting
    Date of First Enrollment 2018-07-19 Actual
    Target Number of Participant 122
    Primary Completion Date 2022-04-28 , Anticipated
    Study Completion Date 2022-05-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2018-12-31 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Yeongnam University Medical Center
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-02-25 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Kyungpook National University Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-05-30 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Seoul National University Bundang Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 대상자 등록 없이 종료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 5
    Name of Study Seoul National University Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2018-07-19 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Asan Medical Center
    Recruitment Status Withdrawn Withdrawn Reason : 대상자 등록 없이 종료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 7
    Name of Study Samsung Medical Center
    Recruitment Status Withdrawn Withdrawn Reason : 대상자 등록 없이 종료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 8
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 대상자 등록 없이 종료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 9
    Name of Study Pusan National University Yangsan Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 대상자 등록 없이 종료
    Date of First Enrollment
    Recruitment Status by Participating Study Site 10
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-05-20 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Chonnam National University Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-01-04 ,
    Recruitment Status by Participating Study Site 12
    Name of Study Incheon Sejong Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2019-07-10 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Korea University Anam Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 대상자 등록 없이 종료
    Date of First Enrollment

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Medtronic Korea
    Organization Type Others
    Project ID CR3857

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Keimyung University Dongsan Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay 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.

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 122
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patient of Valvular heart disease

    Cohort/Group Description

    Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death.

- pulse, blood pressure, EKG, checking ICD
- optional) weight, blood test, ECHO, 24 hours holter monitoring
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
    • 
						
  • 
							
    
								
    
									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death.
    		
											
    
											
    
												Sampling Method
												
    Patients with left ventricular dysfunction due to valvular heart disease and with intermittent defibrillation as primary prevention of sudden death are selected by non-stochastic extraction.
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												* (I00-I99)Diseases of the circulatory system 
    
												
												
												   (I09.9)Rheumatic heart disease, unspecified 
												
												
												

    
												As a Patients who EF ≤ 35% due to clinically significant valvular disease of the heart and received an implantable cardioverter-defibrillator for primary prevention of sudden death.
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												19Year~75Year
											    		
										
    
										
    
											
												
    Description
    
												
    •Adults 19 to 75 years
•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
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													
													No
												
											
										
    
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											Efficacy
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy
    		
											
    
											
    
												Timepoint
												
    Two year after study enrollment
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    mortality was recorded and it will be classified into cardiogenic/non-cardiogenic death. Especially, arrhythmic death was recorded separately.
    		
											
    
											
    
												Timepoint
												
    Two year after study enrollment
    		
											
    
										
											
    
												
													Secondary Outcome(s) 2
												
											
    
											
    
												Outcome
												
    Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia)
    		
											
    
											
    
												Timepoint
												
    Two year after study enrollment
    		
											
    
										
											
    
												
													Secondary Outcome(s) 3
												
											
    
											
    
												Outcome
												
    Analyze the type of ventricular arrhythmia
    		
											
    
											
    
												Timepoint
												
    Two year after study enrollment
    		
											
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									11. Study Results and Publication
								
    
								
							
    
							
    
								
    
									Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
									
										
    
											Result Registered
											
												
													
													No
												
												
												
											
										
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
								
    
								
							
    
							
    
								
    
									Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
									
										
    
											Sharing Statement
											
												
													
													No
													
												
											
										
    
										
									    
								
    
							
    
						
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