ID

18704

Description

SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation; ODM derived from: https://clinicaltrials.gov/show/NCT00419640

Lien

https://clinicaltrials.gov/show/NCT00419640

Mots-clés

  1. 17/11/2016 17/11/2016 -
Téléchargé le

17 novembre 2016

DOI

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Licence

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT00419640

Eligibility Atrial Fibrillation NCT00419640

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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:
Description

Paroxysmal atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C0235480
holter documentation and the strip must be at least 30 seconds; or
Description

Holter documentation

Type de données

boolean

Alias
UMLS CUI [1]
C0013801
one page of 12-lead electrocardiogram (ecg); or
Description

12-lead electrocardiogram

Type de données

boolean

Alias
UMLS CUI [1]
C0430456
transtelephonic recording for more than 15 seconds.
Description

Transtelephonic recording

Type de données

boolean

Alias
UMLS CUI [1]
C0180305
2. have a conventional indication for a pacemaker due to either sinus or atrioventricular (av) node diseases.
Description

Indication for a pacemaker due to either sinus or atrioventricular node diseases

Type de données

boolean

Alias
UMLS CUI [1]
C0428908
UMLS CUI [2]
C0741301
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0030163
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.
Description

Informed Consent, Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
4. be at least 18 years old.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. already implanted with a pacemaker or implantable cardioverter defibrillator (icd).
Description

Pacemaker or implantable cardioverter defibrillator

Type de données

boolean

Alias
UMLS CUI [1]
C0182148
UMLS CUI [2]
C0162589
2. are expected to have heart surgery within the next 6 months.
Description

Heart surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0018821
3. have angina pectoris, new york heart association (nyha) class iii or class iv.
Description

Angina Pectoris, NYHA

Type de données

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1275491
4. are expected not to be able to tolerate high rate pacing.
Description

Unable to tolerate high rate pacing

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0199640
5. have less than 12 months' life expectancy.
Description

Life expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
6. are on the cardiac transplantation list.
Description

Cardiac transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C3275052
7. are in chronic af.
Description

Chronic atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C0694539
8. have a reversible aetiology of af (e.g., hyperthyroidism, acute post-cardiac surgery af, etc.).
Description

reversible aetiology of atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0743625
UMLS CUI [1,2]
C0004238

Similar models

Eligibility Atrial Fibrillation NCT00419640

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Age
Item
4. be at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])

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