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ID

17415

Descrizione

Safety and Efficacy Study of RENEWAL 4 AVT; ODM derived from: https://clinicaltrials.gov/show/NCT00180336

collegamento

https://clinicaltrials.gov/show/NCT00180336

Keywords

  1. 12/09/16 12/09/16 -
Caricato su

12 settembre 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Heart Failure NCT00180336

    Eligibility Heart Failure NCT00180336

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    indications for the device
    Descrizione

    Indication Medical Device

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0025080
    availability for follow-up at an approved field following center, at the protocol defined intervals
    Descrizione

    Study Protocol Interval Follow-up Availability

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C1272706
    UMLS CUI [1,3]
    C3274571
    UMLS CUI [1,4]
    C0470187
    willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
    Descrizione

    Device implant Willing | Testing participation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0948629
    UMLS CUI [1,2]
    C0600109
    UMLS CUI [2,1]
    C0039593
    UMLS CUI [2,2]
    C0679823
    prescribed to stable optimal pharmacologic therapy for hf
    Descrizione

    Heart failure Pharmacotherapy Optimal Stable

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0013216
    UMLS CUI [1,3]
    C2698651
    UMLS CUI [1,4]
    C0205360
    age 18 or above, or of legal age to give informed consent specific to national law
    Descrizione

    Age | Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0021430
    able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion.
    Descrizione

    Atrial Fibrillation Episode Quantity Evidence | Atrial Tachyarrhythmia Episode Quantity Evidence | Anticoagulation Therapy Recommended

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0004238
    UMLS CUI [1,2]
    C0332189
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0332120
    UMLS CUI [2,1]
    C0080203
    UMLS CUI [2,2]
    C0018792
    UMLS CUI [2,3]
    C0332189
    UMLS CUI [2,4]
    C1265611
    UMLS CUI [2,5]
    C0332120
    UMLS CUI [3,1]
    C0003281
    UMLS CUI [3,2]
    C0034866
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    right bundle branch block morphology
    Descrizione

    Right bundle branch block Morphology

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0085615
    UMLS CUI [1,2]
    C0332437
    life expectancy of less than six months due to other medical conditions
    Descrizione

    Life Expectancy Due to Other medical condition

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0023671
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C3843040
    expectation of a heart transplant during the period of the study
    Descrizione

    Heart Transplantation Expected

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0018823
    UMLS CUI [1,2]
    C1517001
    patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
    Descrizione

    Mechanical heart valve prosthesis Tricuspid valve

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3873910
    UMLS CUI [1,2]
    C0040960
    have a preexisting unipolar pacemaker that will not be explanted/abandoned
    Descrizione

    Artificial cardiac pacemaker Unipolar Pre-existing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0030163
    UMLS CUI [1,2]
    C0443340
    UMLS CUI [1,3]
    C2347662
    have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
    Descrizione

    Atrial Tachyarrhythmia Permanent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0080203
    UMLS CUI [1,2]
    C0018792
    UMLS CUI [1,3]
    C0205355
    have a known hypersensitivity to dexamethasone acetate
    Descrizione

    Hypersensitivity dexamethasone acetate

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0057598
    enrolled in any other study, including drug investigation
    Descrizione

    Study Subject Participation Status | Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    women that are pregnant or planning to become pregnant
    Descrizione

    Pregnancy | Pregnancy, Planned

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0032992
    a cerebral vascular event/ transient ischemic attack within 12 months of implantation
    Descrizione

    Cerebrovascular accident | Transient Ischemic Attack

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    UMLS CUI [2]
    C0007787
    during the four weeks prior to implantation, a patient experiences an episode of af >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (inr >= 2.0) for the 4 weeks prior to enrollment
    Descrizione

    Atrial Fibrillation Episode Duration | Anticoagulation Therapy Inadequate | International Normalized Ratio

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0004238
    UMLS CUI [1,2]
    C0332189
    UMLS CUI [1,3]
    C0449238
    UMLS CUI [2,1]
    C0003281
    UMLS CUI [2,2]
    C0205412
    UMLS CUI [3]
    C0525032

    Similar models

    Eligibility Heart Failure NCT00180336

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Indication Medical Device
    Item
    indications for the device
    boolean
    C3146298 (UMLS CUI [1,1])
    C0025080 (UMLS CUI [1,2])
    Study Protocol Interval Follow-up Availability
    Item
    availability for follow-up at an approved field following center, at the protocol defined intervals
    boolean
    C2348563 (UMLS CUI [1,1])
    C1272706 (UMLS CUI [1,2])
    C3274571 (UMLS CUI [1,3])
    C0470187 (UMLS CUI [1,4])
    Device implant Willing | Testing participation
    Item
    willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
    boolean
    C0948629 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    C0039593 (UMLS CUI [2,1])
    C0679823 (UMLS CUI [2,2])
    Heart failure Pharmacotherapy Optimal Stable
    Item
    prescribed to stable optimal pharmacologic therapy for hf
    boolean
    C0018801 (UMLS CUI [1,1])
    C0013216 (UMLS CUI [1,2])
    C2698651 (UMLS CUI [1,3])
    C0205360 (UMLS CUI [1,4])
    Age | Informed Consent
    Item
    age 18 or above, or of legal age to give informed consent specific to national law
    boolean
    C0001779 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Atrial Fibrillation Episode Quantity Evidence | Atrial Tachyarrhythmia Episode Quantity Evidence | Anticoagulation Therapy Recommended
    Item
    able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion.
    boolean
    C0004238 (UMLS CUI [1,1])
    C0332189 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0332120 (UMLS CUI [1,4])
    C0080203 (UMLS CUI [2,1])
    C0018792 (UMLS CUI [2,2])
    C0332189 (UMLS CUI [2,3])
    C1265611 (UMLS CUI [2,4])
    C0332120 (UMLS CUI [2,5])
    C0003281 (UMLS CUI [3,1])
    C0034866 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Right bundle branch block Morphology
    Item
    right bundle branch block morphology
    boolean
    C0085615 (UMLS CUI [1,1])
    C0332437 (UMLS CUI [1,2])
    Life Expectancy Due to Other medical condition
    Item
    life expectancy of less than six months due to other medical conditions
    boolean
    C0023671 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C3843040 (UMLS CUI [1,3])
    Heart Transplantation Expected
    Item
    expectation of a heart transplant during the period of the study
    boolean
    C0018823 (UMLS CUI [1,1])
    C1517001 (UMLS CUI [1,2])
    Mechanical heart valve prosthesis Tricuspid valve
    Item
    patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
    boolean
    C3873910 (UMLS CUI [1,1])
    C0040960 (UMLS CUI [1,2])
    Artificial cardiac pacemaker Unipolar Pre-existing
    Item
    have a preexisting unipolar pacemaker that will not be explanted/abandoned
    boolean
    C0030163 (UMLS CUI [1,1])
    C0443340 (UMLS CUI [1,2])
    C2347662 (UMLS CUI [1,3])
    Atrial Tachyarrhythmia Permanent
    Item
    have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
    boolean
    C0080203 (UMLS CUI [1,1])
    C0018792 (UMLS CUI [1,2])
    C0205355 (UMLS CUI [1,3])
    Hypersensitivity dexamethasone acetate
    Item
    have a known hypersensitivity to dexamethasone acetate
    boolean
    C0020517 (UMLS CUI [1,1])
    C0057598 (UMLS CUI [1,2])
    Study Subject Participation Status | Investigational New Drugs
    Item
    enrolled in any other study, including drug investigation
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Pregnancy | Pregnancy, Planned
    Item
    women that are pregnant or planning to become pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0032992 (UMLS CUI [2])
    Cerebrovascular accident | Transient Ischemic Attack
    Item
    a cerebral vascular event/ transient ischemic attack within 12 months of implantation
    boolean
    C0038454 (UMLS CUI [1])
    C0007787 (UMLS CUI [2])
    Atrial Fibrillation Episode Duration | Anticoagulation Therapy Inadequate | International Normalized Ratio
    Item
    during the four weeks prior to implantation, a patient experiences an episode of af >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (inr >= 2.0) for the 4 weeks prior to enrollment
    boolean
    C0004238 (UMLS CUI [1,1])
    C0332189 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    C0003281 (UMLS CUI [2,1])
    C0205412 (UMLS CUI [2,2])
    C0525032 (UMLS CUI [3])

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