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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02139449
Enrollment
1000
Registered
2014-05-15
Start date
2014-04-30
Completion date
2024-04-30
Last updated
2019-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

CRT, heart failure, ICD

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.

Interventions

PROCEDUREICD/CRT

cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \>=18 2. LV ejection fraction \<40% or Clinical HF Symptom with (LV ejection fraction \>40%) 3. medication for at least 3month

Exclusion criteria

1\. patient who refuse to enroll the study

Design outcomes

Primary

MeasureTime frameDescription
Transthoracic echocardiography (TTE)before enrollment
EKGbefore enrollmentfor Ventricular arrhythmia events
NYHA(New York Heart Association) evaluationbefore enrollmentFor 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 minute walking testbefore enrollmentfor functional capacity

Secondary

MeasureTime frameDescription
Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)before enrollmentEQ-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).
Cardiac MRI or Cardiac CTbefore enrollment

Countries

South Korea

Contacts

Primary ContactBoyoung Joung, MD, PhD
cby6908@yuhs.ac82-2-2228-8460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026