ID

39405

Description

Evaluation of Left Ventricular Autothreshold, Phase Two; ODM derived from: https://clinicaltrials.gov/show/NCT01242722

Link

https://clinicaltrials.gov/show/NCT01242722

Keywords

Versions (1)
  1. 1/8/20 1/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 8, 2020

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01242722

English

Eligibility Heart Failure NCT01242722

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have a cognis crt-d device implanted for at least 24 hours, with or without a right atrial lead
Description

Implantation of CRT-D Specified | Atrial Lead Right | Atrial Lead Right Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C2825198
UMLS CUI [2,2]
C0444532
UMLS CUI [3,1]
C2825198
UMLS CUI [3,2]
C0444532
UMLS CUI [3,3]
C0332197
patients who have an active lv bipolar lead
Description

Left ventricle Lead Bipolar

Data type

boolean

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

Right ventricle Defibrillation Lead

Data type

boolean

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

Participation Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0039593
patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
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

CRT-D | Battery Status Reduced

Data type

boolean

Alias
UMLS CUI [1]
C1135480
UMLS CUI [2,1]
C1704779
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0392756
patients who are pacemaker-dependent
Description

Pacemaker Dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0439857
patients who will not tolerate a pacing pause of up to 6 seconds
Description

Intolerant Pacing Pause

Data type

boolean

Alias
UMLS CUI [1,1]
C0231200
UMLS CUI [1,2]
C0199640
UMLS CUI [1,3]
C0489607
patients who have a unipolar lv pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
Description

Left ventricle Pacing Lead Unipolar

Data type

boolean

Alias
UMLS CUI [1,1]
C0225897
UMLS CUI [1,2]
C0199640
UMLS CUI [1,3]
C0181586
UMLS CUI [1,4]
C0443340
patients with pre-existing leads other than those specified in this investigational plan
Description

Leads Pre-existing | Exception Leads Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0181586
UMLS CUI [2,3]
C2348563
patients with a pre-existing unipolar pacemaker
Description

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 40-50 minutes
Description

Supine Position Number of minutes Unable | Supine Position Number of minutes Unwilling | Sitting position Number of minutes Unable | Sitting position Number of minutes Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038846
UMLS CUI [1,2]
C1562039
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0038846
UMLS CUI [2,2]
C1562039
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0277814
UMLS CUI [3,2]
C1562039
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0277814
UMLS CUI [4,2]
C1562039
UMLS CUI [4,3]
C0558080
patients enrolled in any concurrent study, without boston scientific 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
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Heart Failure NCT01242722

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantation of CRT-D Specified | Atrial Lead Right | Atrial Lead Right Absent
Item
patients who have a cognis crt-d device implanted for at least 24 hours, with or without a right atrial lead
boolean
C1135480 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C2825198 (UMLS CUI [2,1])
C0444532 (UMLS CUI [2,2])
C2825198 (UMLS CUI [3,1])
C0444532 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Left ventricle Lead Bipolar
Item
patients who have an active lv bipolar lead
boolean
C0225897 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C0443156 (UMLS CUI [1,3])
Right ventricle Defibrillation Lead
Item
patients who have an active right ventricular (rv) defibrillation lead
boolean
C0225883 (UMLS CUI [1,1])
C0013778 (UMLS CUI [1,2])
C0181586 (UMLS CUI [1,3])
Participation Testing
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])
Age | 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])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
CRT-D | Battery Status Reduced
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])
C1704779 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0392756 (UMLS CUI [2,3])
Pacemaker Dependence
Item
patients who are pacemaker-dependent
boolean
C0030163 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
Intolerant Pacing Pause
Item
patients who will not tolerate a pacing pause of up to 6 seconds
boolean
C0231200 (UMLS CUI [1,1])
C0199640 (UMLS CUI [1,2])
C0489607 (UMLS CUI [1,3])
Left ventricle Pacing Lead Unipolar
Item
patients who have a unipolar lv pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
boolean
C0225897 (UMLS CUI [1,1])
C0199640 (UMLS CUI [1,2])
C0181586 (UMLS CUI [1,3])
C0443340 (UMLS CUI [1,4])
Leads Pre-existing | Exception Leads Study Protocol
Item
patients with pre-existing leads other than those specified in this investigational plan
boolean
C0181586 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0181586 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
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])
Supine Position Number of minutes Unable | Supine Position Number of minutes Unwilling | Sitting position Number of minutes Unable | Sitting position Number of minutes Unwilling
Item
patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
boolean
C0038846 (UMLS CUI [1,1])
C1562039 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0038846 (UMLS CUI [2,1])
C1562039 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0277814 (UMLS CUI [3,1])
C1562039 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0277814 (UMLS CUI [4,1])
C1562039 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Study Subject Participation Status | Clinical Trial
Item
patients enrolled in any concurrent study, without boston scientific written approval
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pregnancy
Item
women who are pregnant
boolean
C0032961 (UMLS CUI [1])
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