Description:

ODM derived from http://clinicaltrials.gov/show/NCT00450684

Link:

http://clinicaltrials.gov/show/NCT00450684

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00450684 Congenital Heart Defects

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
congenital heart defect
morphologic heart failure of the right or left system ventricle with an ejection fraction of absolute <= 40%
NYHA II - IV
optimal drug therapy for heart failure according to the ESC guidelines
QRS-interval >= 120 ms (according to at least two ECG)
chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above mentioned criteria
morphologically right ventricle in system position and significant insufficiency of the systemic AV valve, which also meets the above mentioned criteria
electromechanic dyssynchrony as defined in study protocol
Exclusion Criteria
PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy
pulmonary hypertension/Eisenmenger syndrome
univentricular heart without Fontan procedure
life expectancy less than 1 year due to a non-cardiac disease
expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation
ergospirometry cannot be performed
Pregnancy, Gestation
participation in a clinical trial within the last 4 weeks or current participation in a clinical trial (except studies of the Competence Network for Congenital Heart Defects)
diseases or functional disorders that exclude participation according to physician's convenience
Uncooperative behavior
known or continuous drug or alcohol abuse