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

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ClinicalTrials.gov Identifier: NCT03590730
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Valvular Heart Disease Implantable Cardioverter Defibrillator Sudden Cardiac Death Primary Prevention Device: ICD implantation

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Study Type : Observational
Estimated Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Incidence of Appropriate ICD therapy [ Time Frame: Two year after study enrollment ]
    ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Two year after study enrollment ]
    mortality was recorded and it will be classified into cardiogenic/non-cardiogenic death. Especially, arrhythmic death was recorded separately.

  2. Incidence of inappropriate ICD therapy [ Time Frame: Two year after study enrollment ]
    Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia)

  3. Type of ventricular arrhythmia [ Time Frame: Two year after study enrollment ]
    Analyze the type of ventricular arrhythmia



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590730


Contacts
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Contact: Jongmin Hwang, MD, Ph D +82-053-250-7333 dsmcep@dsmc.or.kr

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
Contact: Ki Won Hwang, MD         
Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Contact: Myung Hwan Bae, MD, PhD         
Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Contact: Dong Gu Shin, MD, PhD         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of, 61469
Contact: Hyung Wook Park, MD, PhD         
Mediplex Sejong Hospital Recruiting
Incheon, Korea, Republic of, 21080
Contact: Sang Won Park, MD         
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 13620
Contact: Youngjin Cho, MD, Ph D         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Jong-Il Choi, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Eue-Keun Choi, MD, PhD         
Severance Cardiovascular Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Boyoung Joung, MD, PhD         
Seoul Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jun Kim, MD, PhD         
Seoul Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Young Keun On, MD, PhD         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Yong‐Seog Oh, MD, Ph D         
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Medtronic
Investigators
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Principal Investigator: Seongwook Han, MD, Ph D Keimyung University Dongsan Medical Center

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Responsible Party: Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03590730     History of Changes
Other Study ID Numbers: 2017-08-027-007
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Death
Death, Sudden, Cardiac
Heart Valve Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden