Eligibility NCT00450684 Congenital Heart Defects

congenital heart defect

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morphologic heart failure of the right or left system ventricle with an ejection fraction of absolute <= 40%

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NYHA II - IV

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optimal drug therapy for heart failure according to the ESC guidelines

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QRS-interval >= 120 ms (according to at least two ECG)

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chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above mentioned criteria

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morphologically right ventricle in system position and significant insufficiency of the systemic AV valve, which also meets the above mentioned criteria

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electromechanic dyssynchrony as defined in study protocol

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PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy

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pulmonary hypertension/Eisenmenger syndrome

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univentricular heart without Fontan procedure

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life expectancy less than 1 year due to a non-cardiac disease

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expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation

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ergospirometry cannot be performed

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Schwangerschaft

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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)

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diseases or functional disorders that exclude participation according to physician's convenience

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Nein

nicht-kooperatives Verhalten

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known or continuous drug or alcohol abuse

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Nein