Informatie:
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ID
18704
Beschrijving
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation; ODM derived from: https://clinicaltrials.gov/show/NCT00419640
Link
https://clinicaltrials.gov/show/NCT00419640
Trefwoorden
Versies (1)
- 17-11-16 17-11-16 -
Geüploaded op
17 november 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00419640
Eligibility Atrial Fibrillation NCT00419640
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT00419640
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Paroxysmal atrial fibrillation
Item
1. have a history of paroxysmal af with documented af episode within the last 6 months; documentation of af is required. it can be documented by one of the following:
boolean
C0235480 (UMLS CUI [1])
Holter documentation
Item
holter documentation and the strip must be at least 30 seconds; or
boolean
C0013801 (UMLS CUI [1])
12-lead electrocardiogram
Item
one page of 12-lead electrocardiogram (ecg); or
boolean
C0430456 (UMLS CUI [1])
Transtelephonic recording
Item
transtelephonic recording for more than 15 seconds.
boolean
C0180305 (UMLS CUI [1])
Indication for a pacemaker due to either sinus or atrioventricular node diseases
Item
2. have a conventional indication for a pacemaker due to either sinus or atrioventricular (av) node diseases.
boolean
C0428908 (UMLS CUI [1])
C0741301 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0030163 (UMLS CUI [3,2])
C0741301 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0030163 (UMLS CUI [3,2])
Informed Consent, Compliance
Item
3. provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C1321605 (UMLS CUI [2])
Age
Item
4. be at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Pacemaker or implantable cardioverter defibrillator
Item
1. already implanted with a pacemaker or implantable cardioverter defibrillator (icd).
boolean
C0182148 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C0162589 (UMLS CUI [2])
Heart surgery
Item
2. are expected to have heart surgery within the next 6 months.
boolean
C0018821 (UMLS CUI [1])
Angina Pectoris, NYHA
Item
3. have angina pectoris, new york heart association (nyha) class iii or class iv.
boolean
C0002962 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C1275491 (UMLS CUI [2])
Unable to tolerate high rate pacing
Item
4. are expected not to be able to tolerate high rate pacing.
boolean
C1301624 (UMLS CUI [1,1])
C0199640 (UMLS CUI [1,2])
C0199640 (UMLS CUI [1,2])
Life expectancy
Item
5. have less than 12 months' life expectancy.
boolean
C0023671 (UMLS CUI [1])
Cardiac transplantation
Item
6. are on the cardiac transplantation list.
boolean
C3275052 (UMLS CUI [1])
Chronic atrial fibrillation
Item
7. are in chronic af.
boolean
C0694539 (UMLS CUI [1])
reversible aetiology of atrial fibrillation
Item
8. have a reversible aetiology of af (e.g., hyperthyroidism, acute post-cardiac surgery af, etc.).
boolean
C0743625 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,2])