Description:

ODM derived from http://clinicaltrials.gov/show/NCT00729703

Link:

http://clinicaltrials.gov/show/NCT00729703

Keywords:
Versions (2) ▾
  1. 12/6/13
  2. 4/16/14
Uploaded on:

April 16, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00729703 Tachycardia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
An optimal (as determined by the enrolling physician) medical regimen.
Patient's Signature on Informed Consent Form
Exclusion Criteria
Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
Any contraindication for ICD therapy and the implant of a dual chamber ICD.
ICD replacement
Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
A PR interval > 250 ms or AR interval > 300 ms measured at implant.
Idiopathic hypertrophic subaortic stenosis
Acute myocarditis
Unstable coronary symptoms or myocardial infarction within the last month.
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
Recently performed (in the last month) or planned cardiac surgery
Already included in another clinical study.
Life expectancy less than 24 months.
Inability to understand the purpose of the study or refusal to cooperate.
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
Unavailability for scheduled follow-up at the implanting or cooperating center.
Age < 18 years
Pregnancy, Gestation