Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)

Study Overview
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Brief Summary
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CRT and ICD has known as decreasing cardiac mortality in patient with heart failure. Especially, it has reported that CRT improved cardiac systolic function, quality of life of patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So the investigators will register patients who implant CRT or ICD (primary), and follow them up. During scheduled follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter monitoring and questionnaire on QOL.

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Procedure: ICD/CRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 LV ejection fraction <40% or Clinical HF Symptom with (LV ejection fraction >40%) medication for at least 3month Exclusion Criteria: 1. patient who refuse to enroll the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD/CRT registry<br>ICD / CRTregistry in Severance or Ewha Womans University Medical Center | Procedure: ICD/CRT<br>* cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transthoracic echocardiography (TTE) |  | before enrollment | 
| Transthoracic echocardiography (TTE) |  | 12 month later afer enrollment | 
| EKG | for Ventricular arrhythmia events | before enrollment | 
| EKG | for Ventricular arrhythmia events | 1 month later after enrollment | 
| EKG | for Ventricular arrhythmia events | 6 month later after enrollment | 
| EKG | for Ventricular arrhythmia events | 12 month later after enrollment | 
| NYHA(New York Heart Association) evaluation | For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. | before enrollment | 
| NYHA(New York Heart Association) evaluation | For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. | 1 month later after enrollment | 
| NYHA(New York Heart Association) evaluation | For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. | 6 month later after enrollment | 
| NYHA(New York Heart Association) evaluation | For functional capacity - The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. | 12 month later after enrollment | 
| 6 minute walking test | for functional capacity | before enrollment | 
| 6 minute walking test | for functional capacity | 12 month later afer enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional) | EQ-5D-3L is the scale used in the health state description part was three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). | before enrollment | 
| Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional) | EQ-5D-3L is the scale used in the health state description part was three-level; having no problems, having some or moderate problems, being unable to do/having extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). | 12 month later afer enrollment | 
| Cardiac MRI or Cardiac CT |  | before enrollment | 
| Cardiac MRI or Cardiac CT |  | 12 month later afer enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, heart failure, ICD