ID

43050

Description

Evaluation of a New Cardiac Pacemaker; ODM derived from: https://clinicaltrials.gov/show/NCT01700244

Link

https://clinicaltrials.gov/show/NCT01700244

Keywords

  1. 8/13/19 8/13/19 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block NCT01700244

Eligibility Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block NCT01700244

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must have one of the following clinical indications:
Description

Indication Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1265611
1. chronic atrial fibrillation with 2 or 3° av or bifascicular bundle branch block (bbb block) ; or
Description

Chronic atrial fibrillation | Second degree atrioventricular block | Complete atrioventricular block | Bifascicular bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0694539
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4]
C0264914
2. normal sinus rhythm with 2 or 3° av or bbb block and a low level of physical activity or short expected lifespan (but at least one year); or
Description

Normal sinus rhythm | Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Physical activity decreased | Life Expectancy Short

Data type

boolean

Alias
UMLS CUI [1]
C0232202
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4]
C0006384
UMLS CUI [5]
C0391853
UMLS CUI [6,1]
C0023671
UMLS CUI [6,2]
C1806781
3. sinus bradycardia with infrequent pauses or unexplained syncope with ep findings; and
Description

Sinus bradycardia | Pauses Infrequent | Syncope Unexplained | Electrophysiology Finding

Data type

boolean

Alias
UMLS CUI [1]
C0085610
UMLS CUI [2,1]
C0489607
UMLS CUI [2,2]
C0521114
UMLS CUI [3,1]
C0039070
UMLS CUI [3,2]
C4288071
UMLS CUI [4,1]
C1446476
UMLS CUI [4,2]
C0243095
subject ≥18 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has life expectancy of at least one year;
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
subject is not enrolled in another clinical investigation;
Description

Enrollment Absent Clinical Trial Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205394
subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the ec;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
if female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
Description

Gender Contraceptive methods | Postoperative Period | Gender Sexual Abstinence | Female Sterilization | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0032790
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pacemaker dependent;
Description

Artificial cardiac pacemaker dependent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C3244310
known pacemaker syndrome, have retrograde va conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
Description

Cardiac pacemaker syndrome | Ventriculo-atrial conduction Retrograde | Hypotension Due to Intraventricular pacing

Data type

boolean

Alias
UMLS CUI [1]
C0340929
UMLS CUI [2,1]
C2021176
UMLS CUI [2,2]
C0439784
UMLS CUI [3,1]
C0020649
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0199648
hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
Description

Hypersensitivity Dexamethasone sodium phosphate Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0113286
UMLS CUI [1,3]
C0178602
mechanical tricuspid valve prosthesis;
Description

Tricuspid valve prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C1322659
pre-existing pulmonary arterial (pa) hypertension or significant physiologically-impairing lung disease;
Description

Pulmonary arterial hypertension Pre-existing | Lung disease Impairing

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0221099
pre-existing pacing or defibrillation leads;
Description

Cardiac pacing Leads Pre-existing | Defibrillation Leads Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0199640
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0013778
UMLS CUI [2,2]
C0181586
UMLS CUI [2,3]
C2347662
current implantation of an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt);
Description

Implantable defibrillator insertion | Cardiac Resynchronization Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0877213
UMLS CUI [2]
C1167956
presence of implanted vena cava filter;
Description

Vena cava filter insertion

Data type

boolean

Alias
UMLS CUI [1]
C0877093
presence of implanted leadless cardiac pacemaker;
Description

Leadless cardiac pacemaker Implanted

Data type

boolean

Alias
UMLS CUI [1,1]
C4064686
UMLS CUI [1,2]
C0021102
pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block NCT01700244

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Quantity
Item
subject must have one of the following clinical indications:
boolean
C3146298 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Chronic atrial fibrillation | Second degree atrioventricular block | Complete atrioventricular block | Bifascicular bundle branch block
Item
1. chronic atrial fibrillation with 2 or 3° av or bifascicular bundle branch block (bbb block) ; or
boolean
C0694539 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0264914 (UMLS CUI [4])
Normal sinus rhythm | Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Physical activity decreased | Life Expectancy Short
Item
2. normal sinus rhythm with 2 or 3° av or bbb block and a low level of physical activity or short expected lifespan (but at least one year); or
boolean
C0232202 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0006384 (UMLS CUI [4])
C0391853 (UMLS CUI [5])
C0023671 (UMLS CUI [6,1])
C1806781 (UMLS CUI [6,2])
Sinus bradycardia | Pauses Infrequent | Syncope Unexplained | Electrophysiology Finding
Item
3. sinus bradycardia with infrequent pauses or unexplained syncope with ep findings; and
boolean
C0085610 (UMLS CUI [1])
C0489607 (UMLS CUI [2,1])
C0521114 (UMLS CUI [2,2])
C0039070 (UMLS CUI [3,1])
C4288071 (UMLS CUI [3,2])
C1446476 (UMLS CUI [4,1])
C0243095 (UMLS CUI [4,2])
Age
Item
subject ≥18 years of age;
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
subject has life expectancy of at least one year;
boolean
C0023671 (UMLS CUI [1])
Enrollment Absent Clinical Trial Other
Item
subject is not enrolled in another clinical investigation;
boolean
C1516879 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Protocol Compliance
Item
subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the ec;
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods | Postoperative Period | Gender Sexual Abstinence | Female Sterilization | Postmenopausal state
Item
if female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032790 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Artificial cardiac pacemaker dependent
Item
pacemaker dependent;
boolean
C0030163 (UMLS CUI [1,1])
C3244310 (UMLS CUI [1,2])
Cardiac pacemaker syndrome | Ventriculo-atrial conduction Retrograde | Hypotension Due to Intraventricular pacing
Item
known pacemaker syndrome, have retrograde va conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
boolean
C0340929 (UMLS CUI [1])
C2021176 (UMLS CUI [2,1])
C0439784 (UMLS CUI [2,2])
C0020649 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0199648 (UMLS CUI [3,3])
Hypersensitivity Dexamethasone sodium phosphate Dosage
Item
hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Tricuspid valve prosthesis
Item
mechanical tricuspid valve prosthesis;
boolean
C1322659 (UMLS CUI [1])
Pulmonary arterial hypertension Pre-existing | Lung disease Impairing
Item
pre-existing pulmonary arterial (pa) hypertension or significant physiologically-impairing lung disease;
boolean
C2973725 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Cardiac pacing Leads Pre-existing | Defibrillation Leads Pre-existing
Item
pre-existing pacing or defibrillation leads;
boolean
C0199640 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0013778 (UMLS CUI [2,1])
C0181586 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
Implantable defibrillator insertion | Cardiac Resynchronization Therapy
Item
current implantation of an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt);
boolean
C0877213 (UMLS CUI [1])
C1167956 (UMLS CUI [2])
Vena cava filter insertion
Item
presence of implanted vena cava filter;
boolean
C0877093 (UMLS CUI [1])
Leadless cardiac pacemaker Implanted
Item
presence of implanted leadless cardiac pacemaker;
boolean
C4064686 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial