ID

39605

Description

Attain Performa(TM) Quadripolar Lead Study; ODM derived from: https://clinicaltrials.gov/show/NCT01751022

Link

https://clinicaltrials.gov/show/NCT01751022

Keywords

  1. 2/2/20 2/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 2, 2020

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 Heart Failure NCT01751022

Eligibility Heart Failure NCT01751022

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is indicated for implant of a crt-d device and left-heart lead per local indications (in us only this is based on class i and ii indications for crt-d implant per hrs/acc/aha guidelines)
Description

Indication Implantation of CRT-D | Indication Left heart Lead

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1135480
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0225809
UMLS CUI [2,3]
C0181586
patient (or legally authorized representative) has signed and dated the study-specific consent form
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is expected to remain available for follow-up visits
Description

Patient Available Follow-up visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
patient understands the study and agrees to comply with study protocol
Description

Comprehension Study Protocol | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a previous lv lead implanted or previous implant attempt within 30 days of enrollment or has ongoing aes from a previous unsuccessful implant attempt
Description

Previously Implanted Cardiac Lead Left ventricle | Implant Attempt Previous | Adverse event Due to Implant Attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C3272252
UMLS CUI [1,2]
C0225897
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C1516084
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0021102
UMLS CUI [3,4]
C1516084
patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
Description

Medical contraindication Cardiac transvenous pacemaker | MECHANICAL HEART-VALVE Right sided

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0336574
UMLS CUI [2,1]
C0493527
UMLS CUI [2,2]
C0444532
patient has had a heart transplant (note: patients waiting for heart transplants are allowed in the study)
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
patient is contraindicated for < 1 mg dexamethasone acetate
Description

Medical contraindication Dexamethasone acetate Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0057598
UMLS CUI [1,3]
C0178602
patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (note: co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from medtronic's study manager)
Description

Study Subject Participation Status | Interference Investigational New Drugs | Interference Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C2346570
patient has a life expectancy less than 180 days
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
Description

Exclusion Criteria Law | Age | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0220866
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
in us, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
Description

Childbearing Potential Requirement Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0427780
patient is unable to tolerate an urgent thoracotomy
Description

Thoracotomy Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0039991
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582

Similar models

Eligibility Heart Failure NCT01751022

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantation of CRT-D | Indication Left heart Lead
Item
patient is indicated for implant of a crt-d device and left-heart lead per local indications (in us only this is based on class i and ii indications for crt-d implant per hrs/acc/aha guidelines)
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0225809 (UMLS CUI [2,2])
C0181586 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
patient (or legally authorized representative) has signed and dated the study-specific consent form
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Age
Item
patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
boolean
C0001779 (UMLS CUI [1])
Patient Available Follow-up visit
Item
patient is expected to remain available for follow-up visits
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Comprehension Study Protocol | Protocol Compliance
Item
patient understands the study and agrees to comply with study protocol
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Previously Implanted Cardiac Lead Left ventricle | Implant Attempt Previous | Adverse event Due to Implant Attempt
Item
patient has a previous lv lead implanted or previous implant attempt within 30 days of enrollment or has ongoing aes from a previous unsuccessful implant attempt
boolean
C3272252 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C0877248 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0021102 (UMLS CUI [3,3])
C1516084 (UMLS CUI [3,4])
Medical contraindication Cardiac transvenous pacemaker | MECHANICAL HEART-VALVE Right sided
Item
patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
boolean
C1301624 (UMLS CUI [1,1])
C0336574 (UMLS CUI [1,2])
C0493527 (UMLS CUI [2,1])
C0444532 (UMLS CUI [2,2])
Heart Transplantation
Item
patient has had a heart transplant (note: patients waiting for heart transplants are allowed in the study)
boolean
C0018823 (UMLS CUI [1])
Medical contraindication Dexamethasone acetate Dose
Item
patient is contraindicated for < 1 mg dexamethasone acetate
boolean
C1301624 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Study Subject Participation Status | Interference Investigational New Drugs | Interference Investigational Medical Device
Item
patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (note: co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from medtronic's study manager)
boolean
C2348568 (UMLS CUI [1])
C0521102 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
Life Expectancy
Item
patient has a life expectancy less than 180 days
boolean
C0023671 (UMLS CUI [1])
Exclusion Criteria Law | Age | Pregnancy | Breast Feeding
Item
patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
boolean
C0680251 (UMLS CUI [1,1])
C0220866 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Childbearing Potential Requirement Pregnancy test negative
Item
in us, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
boolean
C3831118 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,3])
Thoracotomy Receive Unable
Item
patient is unable to tolerate an urgent thoracotomy
boolean
C0039991 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])

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