ID

19371

Description

SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction; ODM derived from: https://clinicaltrials.gov/show/NCT00284830

Link

https://clinicaltrials.gov/show/NCT00284830

Keywords

Versions (1)
  1. 12/22/16 12/22/16 -
Uploaded on

December 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Sick Sinus Syndrome NCT00284830

English

Eligibility Sick Sinus Syndrome NCT00284830

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the study follow-up schedule
Description

Clinical Study Follow-up Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
class i/classii indications for dual chamber pacing
Description

Indication Dual Chamber Pacemaker Class

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2911683
UMLS CUI [1,3]
C3272276
initial implant of a kappa 700, kappa 900, enpulse, or enrhythm dual chamber ipg
Description

DUAL CHAMBER IMPLANTABLE PULSE-GENERATOR Implantation Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C0493526
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0205265
demonstrate 1 to 1 conduction and a qrs interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing
Description

1:1 atrioventricular conduction | QRS interval | Intra-atrial pacing

Data type

boolean

Alias
UMLS CUI [1]
C2215915
UMLS CUI [2]
C2168881
UMLS CUI [3]
C0199647
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
less than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
unwilling or unable to give informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
unwilling or unable to commit to follow-up schedule
Description

Clinical Study Follow-up Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0332268
medical conditions that would preclude the testing required by the protocol or limit study participation
Description

Medical condition Excludes Testing | Medical condition Limiting Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0039593
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0008976
enrolled or intend to participate in another clinical trial during the course of this study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
a life expectancy of less than 2 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
history of continuous atrial fibrillation for the 6 months prior to screen visit
Description

Atrial Fibrillation disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0872146
two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
Description

Chemical cardioversion Quantity | Electric Countershock Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2585199
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0013778
UMLS CUI [2,2]
C1265611
history of persistent second or third degree atrioventricular block
Description

Second degree atrioventricular block persistent | Complete atrioventricular block persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0205322
a prior implant of pacemaker or defibrillator device
Description

Implantation of cardiac pacemaker | Implantation of cardiac defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0189842
UMLS CUI [2]
C0397417
a baseline, pre-paced qrs >120 ms on surface ecg
Description

Electrocardiogram QRS complex

Data type

boolean

Alias
UMLS CUI [1]
C0429098
failure of the 1 to 1 atrioventricular conduction test
Description

1:1 atrioventricular conduction Test failed

Data type

boolean

Alias
UMLS CUI [1,1]
C2215915
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0231175
anticipated major cardiac surgery within the course of the study
Description

Cardiac Surgery Major Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C3840775
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Similar models

Eligibility Sick Sinus Syndrome NCT00284830

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Clinical Study Follow-up Compliance behavior
Item
willing and able to comply with the study follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Indication Dual Chamber Pacemaker Class
Item
class i/classii indications for dual chamber pacing
boolean
C3146298 (UMLS CUI [1,1])
C2911683 (UMLS CUI [1,2])
C3272276 (UMLS CUI [1,3])
DUAL CHAMBER IMPLANTABLE PULSE-GENERATOR Implantation Initial
Item
initial implant of a kappa 700, kappa 900, enpulse, or enrhythm dual chamber ipg
boolean
C0493526 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
1:1 atrioventricular conduction | QRS interval | Intra-atrial pacing
Item
demonstrate 1 to 1 conduction and a qrs interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing
boolean
C2215915 (UMLS CUI [1])
C2168881 (UMLS CUI [2])
C0199647 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Age
Item
less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling
Item
unwilling or unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Clinical Study Follow-up Compliance behavior Lacking
Item
unwilling or unable to commit to follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Medical condition Excludes Testing | Medical condition Limiting Clinical Trial
Item
medical conditions that would preclude the testing required by the protocol or limit study participation
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Study Subject Participation Status
Item
enrolled or intend to participate in another clinical trial during the course of this study
boolean
C2348568 (UMLS CUI [1])
Life Expectancy
Item
a life expectancy of less than 2 years
boolean
C0023671 (UMLS CUI [1])
Atrial Fibrillation disease length
Item
history of continuous atrial fibrillation for the 6 months prior to screen visit
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Chemical cardioversion Quantity | Electric Countershock Quantity
Item
two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
boolean
C2585199 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0013778 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Second degree atrioventricular block persistent | Complete atrioventricular block persistent
Item
history of persistent second or third degree atrioventricular block
boolean
C0264906 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0151517 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Implantation of cardiac pacemaker | Implantation of cardiac defibrillator
Item
a prior implant of pacemaker or defibrillator device
boolean
C0189842 (UMLS CUI [1])
C0397417 (UMLS CUI [2])
Electrocardiogram QRS complex
Item
a baseline, pre-paced qrs >120 ms on surface ecg
boolean
C0429098 (UMLS CUI [1])
1:1 atrioventricular conduction Test failed
Item
failure of the 1 to 1 atrioventricular conduction test
boolean
C2215915 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Cardiac Surgery Major Anticipated
Item
anticipated major cardiac surgery within the course of the study
boolean
C0018821 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
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