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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)

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ClinicalTrials.gov Identifier: NCT02139449
Recruitment Status : Recruiting
First Posted : May 15, 2014
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Congestive Heart Failure Procedure: ICD/CRT

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2014
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
ICD/CRT registry Procedure: ICD/CRT
cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation




Primary Outcome Measures :
  1. Mortality of CHF patients after CRT or ICD implantation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quality of Life of CHF patients after CRT or ICD implantation [ Time Frame: 1 year ]
  2. Functional capacity [ Time Frame: 1 year ]
    1. transthoracic echocardiography (TTE)
    2. EKG, Holter, chest X ray
    3. NYHA evaluation
    4. 6 minute walking test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with congestive heart failure (CHF) who are undergone cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
Criteria

Inclusion Criteria:

  • Age >=18
  • Sinus rhythm
  • QRS ≥120 ms and lef bundle branch block ; LBBB)
  • LV ejection fraction <35%
  • medication for at least 1month

Exclusion Criteria:

  • patient who refuse to enroll the study

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): NCT02139449


Contacts
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Contact: Boyoung Joung, MD, PhD 82-2-2228-8460 cby6908@yuhs.ac

Locations
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Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Boyoung Joung, MD, PhD    82-2-2228-8460    cby6908@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02139449     History of Changes
Other Study ID Numbers: 4-2014-0098
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Yonsei University:
CRT, heart failure, ICD
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases