ID

39512

Description

Iperia/Sentus QP Study; ODM derived from: https://clinicaltrials.gov/show/NCT02181686

Link

https://clinicaltrials.gov/show/NCT02181686

Keywords

Versions (1)
  1. 1/21/20 1/21/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 21, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02181686

English

Eligibility Heart Failure NCT02181686

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is able to understand the nature of the study and provides written informed consent.
Description

Study Protocol Comprehension | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [2]
C0021430
patient meets a standard indication for crt-d (sentus qp group) or icd therapy.
Description

Indication Implantation of CRT-D | Indication Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1135480
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0162589
patient is able and willing to complete the planned follow-up visits at the investigational site.
Description

Follow-up visit Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0205197
patient accepts the home monitoring® concept.
Description

Patient Monitoring At home

Data type

boolean

Alias
UMLS CUI [1,1]
C0030695
UMLS CUI [1,2]
C4534363
age is ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sentus qp group only: patient is a candidate for a new (de novo) implant or an upgrade from an existing icd or pacemaker utilizing a biotronik sentus qp lead
Description

Patient Appropriate Implantable defibrillator | Patient Appropriate Artificial cardiac pacemaker | Use of Lead Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0162589
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0030163
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0181586
UMLS CUI [3,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a standard contraindication for crt-d (sentus qp group) or icd therapy.
Description

Medical contraindication Implantation of CRT-D | Medical contraindication Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1135480
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0162589
sentus qp group only: currently implanted with an endocardial or epicardial lv lead or had prior attempt to place a lv lead.
Description

Left ventricle Lead Implantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0225897
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C0021107
sentus qp group only: cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
Description

Cardiac Surgery Planned | Coronary Artery Bypass Surgery | Valve Surgery | Ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C1186983
UMLS CUI [3,2]
C0543467
UMLS CUI [4]
C0547070
patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
Description

Ventricular assist device Expected | Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0085842
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C1517001
patient is pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
life expectancy of less than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
participating in another cardiac clinical investigation with active treatment arm.
Description

Study Subject Participation Status | Cardiac Clinical Trial with Treatment Arm

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C0332287
UMLS CUI [2,4]
C1522541
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Similar models

Eligibility Heart Failure NCT02181686

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Protocol Comprehension | Informed Consent
Item
patient is able to understand the nature of the study and provides written informed consent.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Indication Implantation of CRT-D | Indication Implantable defibrillator
Item
patient meets a standard indication for crt-d (sentus qp group) or icd therapy.
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0162589 (UMLS CUI [2,2])
Follow-up visit Completion
Item
patient is able and willing to complete the planned follow-up visits at the investigational site.
boolean
C0589121 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Patient Monitoring At home
Item
patient accepts the home monitoring® concept.
boolean
C0030695 (UMLS CUI [1,1])
C4534363 (UMLS CUI [1,2])
Age
Item
age is ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Patient Appropriate Implantable defibrillator | Patient Appropriate Artificial cardiac pacemaker | Use of Lead Specified
Item
sentus qp group only: patient is a candidate for a new (de novo) implant or an upgrade from an existing icd or pacemaker utilizing a biotronik sentus qp lead
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0162589 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0030163 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0181586 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Implantation of CRT-D | Medical contraindication Implantable defibrillator
Item
patient has a standard contraindication for crt-d (sentus qp group) or icd therapy.
boolean
C1301624 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0162589 (UMLS CUI [2,2])
Left ventricle Lead Implantation
Item
sentus qp group only: currently implanted with an endocardial or epicardial lv lead or had prior attempt to place a lv lead.
boolean
C0225897 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
Cardiac Surgery Planned | Coronary Artery Bypass Surgery | Valve Surgery | Ablation
Item
sentus qp group only: cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation.
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
C1186983 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0547070 (UMLS CUI [4])
Ventricular assist device Expected | Heart Transplantation Expected
Item
patient is expected to receive ventricular assist device or heart transplantation within the next 3 months.
boolean
C0085842 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0018823 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
patient is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Cardiac Clinical Trial with Treatment Arm
Item
participating in another cardiac clinical investigation with active treatment arm.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0332287 (UMLS CUI [2,3])
C1522541 (UMLS CUI [2,4])
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