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

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
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
Item
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
boolean
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
Item
Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
boolean
C0553982 (UMLS CUI 2011AA)
275514001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
C0034606 (UMLS CUI 2011AA)
373205008 (SNOMED CT 2011_0131)
10050728 (MedDRA 14.1)
92 (ICD-9-CM Version 2011)
C0013516 (UMLS CUI 2011AA)
40701008 (SNOMED CT 2011_0131)
10014116 (MedDRA 14.1)
88.72 (ICD-9-CM Version 2011)
C0394239 (UMLS CUI 2011AA)
10056448 (MedDRA 14.1)
An optimal (as determined by the enrolling physician) medical regimen.
Item
An optimal (as determined by the enrolling physician) medical regimen.
boolean
C2698651 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
Patient has received all relevant information on the study, and has signed and dated a consent form.
Item
Patient's Signature on Informed Consent Form
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
Item
Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
boolean
CL335836 (UMLS CUI 2011AA)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0199640 (UMLS CUI 2011AA)
18590009 (SNOMED CT 2011_0131)
Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
Item
Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
boolean
CL335836 (UMLS CUI 2011AA)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C2936377 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
Any contraindication for ICD therapy and the implant of a dual chamber ICD.
Item
Any contraindication for ICD therapy and the implant of a dual chamber ICD.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0935616 (UMLS CUI 2011AA)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
ICD replacement
Item
ICD replacement
boolean
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
Item
Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0085611 (UMLS CUI 2011AA)
17366009 (SNOMED CT 2011_0131)
10003656 (MedDRA 14.1)
C0013778 (UMLS CUI 2011AA)
250980009 (SNOMED CT 2011_0131)
10007661 (MedDRA 14.1)
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
A PR interval > 250 ms or AR interval > 300 ms measured at implant.
Item
A PR interval > 250 ms or AR interval > 300 ms measured at implant.
boolean
C0429087 (UMLS CUI 2011AA)
365411005 (SNOMED CT 2011_0131)
10050656 (MedDRA 14.1)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0439117 (UMLS CUI 2011AA)
257974004 (SNOMED CT 2011_0131)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
Hypertrophic obstructive cardiomyopathy.
Item
hypertrophe obstruktive Kardiomyopathie, HOCM, idiopathische hypertrophe Subaortenstenose
boolean
C0700053 (UMLS CUI 2011AA)
360465008 (SNOMED CT 2011_0131)
10021230 (MedDRA 14.1)
I42.1 (ICD-10-CM Version 2010)
Acute myocarditis.
Item
akute Myokarditis, akute Herzmuskelentzündung
boolean
C0155686 (UMLS CUI 2011AA)
46701001 (SNOMED CT 2011_0131)
10000932 (MedDRA 14.1)
I40.9 (ICD-10-CM Version 2010)
422.90 (ICD-9-CM Version 2011)
Unstable coronary symptoms or myocardial infarction within the last month.
Item
Unstable coronary symptoms or myocardial infarction within the last month.
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0018787 (UMLS CUI 2011AA)
80891009 (SNOMED CT 2011_0131)
MTHU001067 (LOINC Version 232)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
Item
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
boolean
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0027056 (UMLS CUI 2011AA)
81266008 (SNOMED CT 2011_0131)
C0190211 (UMLS CUI 2011AA)
41339005 (SNOMED CT 2011_0131)
10050329 (MedDRA 14.1)
Recently performed (in the last month) or planned cardiac surgery
Item
Recently performed (in the last month) or planned cardiac surgery
boolean
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0018821 (UMLS CUI 2011AA)
64915003 (SNOMED CT 2011_0131)
10061026 (MedDRA 14.1)
Already included in another clinical study.
Item
Already included in another clinical study.
boolean
C2348568 (UMLS CUI 2011AA)
Life expectancy less than 24 months.
Item
Life expectancy less than 24 months.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Inability to understand the purpose of the study or refusal to cooperate.
Item
Inability to understand the purpose of the study or refusal to cooperate.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
Item
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
boolean
C1299582 (UMLS CUI 2011AA)
Unavailability for scheduled follow-up at the implanting or cooperating center.
Item
Unavailability for scheduled follow-up at the implanting or cooperating center.
boolean
C1522577 (UMLS CUI 2011AA)
Age < 18 years
Item
Alter < 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pregnancy
Item
Schwangerschaft
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)