ID

39605

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01751022

Trefwoorden

Versies (1)
  1. 02-02-20 02-02-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01751022

Engels

Eligibility Heart Failure NCT01751022

1 Formulieren  
Inclusion Criteria
Beschrijving

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)
Beschrijving

Indication Implantation of CRT-D | Indication Left heart Lead

Datatype

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
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

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
Beschrijving

Age

Datatype

boolean

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

Patient Available Follow-up visit

Datatype

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
Beschrijving

Comprehension Study Protocol | Protocol Compliance

Datatype

boolean

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

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
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

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)
Beschrijving

Heart Transplantation

Datatype

boolean

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

Medical contraindication Dexamethasone acetate Dose

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Life Expectancy

Datatype

boolean

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

Exclusion Criteria Law | Age | Pregnancy | Breast Feeding

Datatype

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
Beschrijving

Childbearing Potential Requirement Pregnancy test negative

Datatype

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
Beschrijving

Thoracotomy Receive Unable

Datatype

boolean

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

Eligibility Heart Failure NCT01751022

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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