ID

43053

Description

Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT); ODM derived from: https://clinicaltrials.gov/show/NCT00677014

Link

https://clinicaltrials.gov/show/NCT00677014

Keywords

Versions (2)
  1. 3/27/18 3/27/18 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00677014

English

Eligibility Heart Failure NCT00677014

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet current indications for a bsc crt-d device with the smartdelay algorithm
Description

Indication Cardiac Resynchronization Therapy Defibrillators

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1322646
patients who are willing and capable of undergoing a device implant and participating in all testing associated with the smart-av study
Description

Device implant Willing | Device implant Capability | Participation Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0948629
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0948629
UMLS CUI [2,2]
C2698977
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C0039593
patients who are on optimal and stable pharmacologic therapy
Description

Pharmacotherapy Optimal Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0205360
patients who are expected to be in sinus rhythm at the time of implant
Description

Sinus rhythm

Data type

boolean

Alias
UMLS CUI [1]
C0232201
patients who have a life expectancy of more than 360 days, per physician's discretion
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients who are geographically stable and willing to comply with the required follow-up schedule
Description

Patient Geographic Stable | Compliance behavior Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1517526
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
Description

Age | Age Legal | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1301860
UMLS CUI [3]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are in complete heart block, or who otherwise are unable to tolerate pacing at vvi-40 rv for up to 14 days
Description

Complete atrioventricular block | Intolerant Pacing Specified

Data type

boolean

Alias
UMLS CUI [1]
C0151517
UMLS CUI [2,1]
C0231200
UMLS CUI [2,2]
C0199640
UMLS CUI [2,3]
C0205369
patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at vvi-40 rv for up to 14 days
Description

Upgrade Artificial cardiac pacemaker | Upgrade Implantable defibrillator | Intolerant Pacing Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C3272274
UMLS CUI [1,2]
C0030163
UMLS CUI [2,1]
C3272274
UMLS CUI [2,2]
C0162589
UMLS CUI [3,1]
C0231200
UMLS CUI [3,2]
C0199640
UMLS CUI [3,3]
C0205369
patients who have previously received cardiac resynchronization therapy
Description

Cardiac Resynchronization Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1167956
patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
Description

Heart Transplantation Expected | Cardiac Surgery procedures Planned | Cardiac therapeutic procedures Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0876964
UMLS CUI [3,2]
C1301732
patients who currently have or who are likely to receive a tricuspid valve prosthesis
Description

Tricuspid valve prosthesis | Tricuspid valve prosthesis Receive Probably

Data type

boolean

Alias
UMLS CUI [1]
C1322659
UMLS CUI [2,1]
C1322659
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0750492
patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
Description

Neuromuscular Disease Preventing Walking | Orthopedic problem Preventing Walking | Condition Preventing Walking | Exception Heart condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0027868
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0080331
UMLS CUI [2,1]
C0029354
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0080331
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0080331
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3842523
patients who are pregnant or planning to become pregnant during the study
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
Description

Study Subject Participation Status Impact Investigational Therapy | Study Subject Participation Status Impact Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0949266
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0683954
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Similar models

Eligibility Heart Failure NCT00677014

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy Defibrillators
Item
patients who meet current indications for a bsc crt-d device with the smartdelay algorithm
boolean
C3146298 (UMLS CUI [1,1])
C1322646 (UMLS CUI [1,2])
Device implant Willing | Device implant Capability | Participation Testing
Item
patients who are willing and capable of undergoing a device implant and participating in all testing associated with the smart-av study
boolean
C0948629 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0948629 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Pharmacotherapy Optimal Stable
Item
patients who are on optimal and stable pharmacologic therapy
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Sinus rhythm
Item
patients who are expected to be in sinus rhythm at the time of implant
boolean
C0232201 (UMLS CUI [1])
Life Expectancy
Item
patients who have a life expectancy of more than 360 days, per physician's discretion
boolean
C0023671 (UMLS CUI [1])
Patient Geographic Stable | Compliance behavior Follow-up
Item
patients who are geographically stable and willing to comply with the required follow-up schedule
boolean
C0030705 (UMLS CUI [1,1])
C1517526 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Age | Age Legal | Informed Consent
Item
patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Complete atrioventricular block | Intolerant Pacing Specified
Item
patients who are in complete heart block, or who otherwise are unable to tolerate pacing at vvi-40 rv for up to 14 days
boolean
C0151517 (UMLS CUI [1])
C0231200 (UMLS CUI [2,1])
C0199640 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Upgrade Artificial cardiac pacemaker | Upgrade Implantable defibrillator | Intolerant Pacing Specified
Item
patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at vvi-40 rv for up to 14 days
boolean
C3272274 (UMLS CUI [1,1])
C0030163 (UMLS CUI [1,2])
C3272274 (UMLS CUI [2,1])
C0162589 (UMLS CUI [2,2])
C0231200 (UMLS CUI [3,1])
C0199640 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Cardiac Resynchronization Therapy
Item
patients who have previously received cardiac resynchronization therapy
boolean
C1167956 (UMLS CUI [1])
Heart Transplantation Expected | Cardiac Surgery procedures Planned | Cardiac therapeutic procedures Planned
Item
patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0876964 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Tricuspid valve prosthesis | Tricuspid valve prosthesis Receive Probably
Item
patients who currently have or who are likely to receive a tricuspid valve prosthesis
boolean
C1322659 (UMLS CUI [1])
C1322659 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
Neuromuscular Disease Preventing Walking | Orthopedic problem Preventing Walking | Condition Preventing Walking | Exception Heart condition
Item
patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
boolean
C0027868 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0029354 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0080331 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0080331 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3842523 (UMLS CUI [4,2])
Pregnancy | Pregnancy, Planned
Item
patients who are pregnant or planning to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Study Subject Participation Status Impact Investigational Therapy | Study Subject Participation Status Impact Research results
Item
patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
boolean
C2348568 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
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