ID

39622

Description

ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0; ODM derived from: https://clinicaltrials.gov/show/NCT01539629

Link

https://clinicaltrials.gov/show/NCT01539629

Keywords

Versions (1)
  1. 2/4/20 2/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01539629

English

Eligibility Heart Failure NCT01539629

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Description

Age | Legal capacity Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0021430
patients who have a cognis crt-d device implanted for at least 24 hours, with or without an active right atrial lead
Description

Implantation of CRT-D | Lead Right atrium | Lead Right atrium Absent

Data type

boolean

Alias
UMLS CUI [1]
C1135480
UMLS CUI [2,1]
C0181586
UMLS CUI [2,2]
C0225844
UMLS CUI [3,1]
C0181586
UMLS CUI [3,2]
C0225844
UMLS CUI [3,3]
C0332197
patients who have an active lv bipolar or unipolar lead
Description

Lead Left ventricle Bipolar | Lead Left ventricle Unipolar

Data type

boolean

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C0225897
UMLS CUI [1,3]
C0443156
UMLS CUI [2,1]
C0181586
UMLS CUI [2,2]
C0225897
UMLS CUI [2,3]
C0443340
patients who have an active rv defibrillation lead
Description

Defibrillation Lead Right ventricle

Data type

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C0225883
patients who are willing and capable of participating in all testing associated with this clinical investigation
Description

Participation Testing Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1517586
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have a cognis crt-d that has less than or equal to one year of battery life remaining
Description

Implantation of CRT-D | End of Expected Battery Life Impending

Data type

boolean

Alias
UMLS CUI [1]
C1135480
UMLS CUI [2,1]
C3275079
UMLS CUI [2,2]
C0332190
patients who are pacemaker-dependent as defined as vvi 40 without intrinsic atrial or ventricular activity
Description

Pacemaker Dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0810633
UMLS CUI [1,2]
C0439857
patients who will not tolerate a pacing pause of up to 6 seconds
Description

Lacking Tolerance Pacing Pause

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0231197
UMLS CUI [1,3]
C0199640
UMLS CUI [1,4]
C0489607
patients with a pre-existing unipolar pacemaker
Description

Artificial cardiac pacemaker Unipolar Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0443340
UMLS CUI [1,3]
C2347662
patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
Description

Maintenance Supine Position Duration Unable | Unable to maintain a sitting position Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0560777
UMLS CUI [2,2]
C0449238
patients enrolled in any concurrent study, without boston scientific crm written approval
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
Description

Pregnancy | Childbearing Potential Requirement Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0427780
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Similar models

Eligibility Heart Failure NCT01539629

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Legal capacity Informed Consent
Item
patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Implantation of CRT-D | Lead Right atrium | Lead Right atrium Absent
Item
patients who have a cognis crt-d device implanted for at least 24 hours, with or without an active right atrial lead
boolean
C1135480 (UMLS CUI [1])
C0181586 (UMLS CUI [2,1])
C0225844 (UMLS CUI [2,2])
C0181586 (UMLS CUI [3,1])
C0225844 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Lead Left ventricle Bipolar | Lead Left ventricle Unipolar
Item
patients who have an active lv bipolar or unipolar lead
boolean
C0181586 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C0443156 (UMLS CUI [1,3])
C0181586 (UMLS CUI [2,1])
C0225897 (UMLS CUI [2,2])
C0443340 (UMLS CUI [2,3])
Defibrillation Lead Right ventricle
Item
patients who have an active rv defibrillation lead
boolean
C0013778 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C0225883 (UMLS CUI [1,3])
Participation Testing Investigational
Item
patients who are willing and capable of participating in all testing associated with this clinical investigation
boolean
C0679823 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Implantation of CRT-D | End of Expected Battery Life Impending
Item
patients who have a cognis crt-d that has less than or equal to one year of battery life remaining
boolean
C1135480 (UMLS CUI [1])
C3275079 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
Pacemaker Dependence
Item
patients who are pacemaker-dependent as defined as vvi 40 without intrinsic atrial or ventricular activity
boolean
C0810633 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
Lacking Tolerance Pacing Pause
Item
patients who will not tolerate a pacing pause of up to 6 seconds
boolean
C0332268 (UMLS CUI [1,1])
C0231197 (UMLS CUI [1,2])
C0199640 (UMLS CUI [1,3])
C0489607 (UMLS CUI [1,4])
Artificial cardiac pacemaker Unipolar Pre-existing
Item
patients with a pre-existing unipolar pacemaker
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
Maintenance Supine Position Duration Unable | Unable to maintain a sitting position Duration
Item
patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
boolean
C0024501 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0560777 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial
Item
patients enrolled in any concurrent study, without boston scientific crm written approval
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pregnancy | Childbearing Potential Requirement Pregnancy test negative
Item
women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0427780 (UMLS CUI [2,3])
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