ID

29459

Beskrivning

Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00758121

Länk

https://clinicaltrials.gov/show/NCT00758121

Nyckelord

Versioner (1)
  1. 2018-03-27 2018-03-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00758121

Engelsk

Eligibility Heart Failure NCT00758121

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
implanted cognis device or future commercially available boston scientific crt-d, that contains the sensor trend for respiratory rate, with a right ventricular lead and left ventricular lead actively implanted
Beskrivning

Implantation of CRT-D | Ventricular Lead Right Implant | Ventricular Lead Left Implant

Datatyp

boolean

Alias
UMLS CUI [1]
C1135480
UMLS CUI [2,1]
C2825199
UMLS CUI [2,2]
C0205090
UMLS CUI [2,3]
C0021102
UMLS CUI [3,1]
C2825199
UMLS CUI [3,2]
C0205091
UMLS CUI [3,3]
C0021102
respiratory sensor programmed "on"
Beskrivning

Sensor respiratory

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0183210
UMLS CUI [1,2]
C0521346
classified as having nyha class iii heart failure documented, in the past 12 months
Beskrivning

Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
age 18 or above, or of legal age to give informed consent specific to state and national law
Beskrivning

Age | Age Legal

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1301860
willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability or refusal to sign the patient informed consent
Beskrivning

Informed Consent Unable | Informed Consent Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
inability or refusal to comply with the follow-up schedule
Beskrivning

Follow-up Compliance behavior Unable | Follow-up Compliance behavior Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C1705116
patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
Beskrivning

Pharmacotherapy | Inotropic agent Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C1522726
patients prescribed to positive airway pressure therapy
Beskrivning

Positive airway pressure therapy prescribed

Datatyp

boolean

Alias
UMLS CUI [1]
C3248586
a life expectancy of less than 180 days, per physician discretion
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
enrolled in any concurrent study without prior written approval from boston scientific crm
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
women who are pregnant or plan to become pregnant in the next twelve months
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Heart Failure NCT00758121

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Implantation of CRT-D | Ventricular Lead Right Implant | Ventricular Lead Left Implant
Item
implanted cognis device or future commercially available boston scientific crt-d, that contains the sensor trend for respiratory rate, with a right ventricular lead and left ventricular lead actively implanted
boolean
C1135480 (UMLS CUI [1])
C2825199 (UMLS CUI [2,1])
C0205090 (UMLS CUI [2,2])
C0021102 (UMLS CUI [2,3])
C2825199 (UMLS CUI [3,1])
C0205091 (UMLS CUI [3,2])
C0021102 (UMLS CUI [3,3])
Sensor respiratory
Item
respiratory sensor programmed "on"
boolean
C0183210 (UMLS CUI [1,1])
C0521346 (UMLS CUI [1,2])
Heart failure New York Heart Association Classification
Item
classified as having nyha class iii heart failure documented, in the past 12 months
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Age | Age Legal
Item
age 18 or above, or of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
Informed Consent | Protocol Compliance
Item
willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Refused
Item
inability or refusal to sign the patient informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Follow-up Compliance behavior Unable | Follow-up Compliance behavior Refused
Item
inability or refusal to comply with the follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
Pharmacotherapy | Inotropic agent Intravenous
Item
patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
boolean
C0013216 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Positive airway pressure therapy prescribed
Item
patients prescribed to positive airway pressure therapy
boolean
C3248586 (UMLS CUI [1])
Life Expectancy
Item
a life expectancy of less than 180 days, per physician discretion
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status
Item
enrolled in any concurrent study without prior written approval from boston scientific crm
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
women who are pregnant or plan to become pregnant in the next twelve months
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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