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Clinical Trials/NCT02139449
NCT02139449
Unknown
N/A

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

Yonsei University1 site in 1 country1,000 target enrollmentApril 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Congestive Heart Failure
Sponsor
Yonsei University
Enrollment
1000
Locations
1
Primary Endpoint
6 minute walking test
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
April 2024
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • LV ejection fraction \<40% or Clinical HF Symptom with (LV ejection fraction \>40%)
  • medication for at least 3month

Exclusion Criteria

  • patient who refuse to enroll the study

Outcomes

Primary Outcomes

6 minute walking test

Time Frame: 12 month later afer enrollment

for functional capacity

Transthoracic echocardiography (TTE)

Time Frame: 12 month later afer enrollment

EKG

Time Frame: 12 month later after enrollment

for Ventricular arrhythmia events

NYHA(New York Heart Association) evaluation

Time Frame: 12 month later after enrollment

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.

Secondary Outcomes

  • Cardiac MRI or Cardiac CT(12 month later afer enrollment)
  • Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)(12 month later afer enrollment)

Study Sites (1)

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