0 Bedömningar

ID

15384

Beskrivning

SynCardia 70cc TAH-t for Destination Therapy (DT); ODM derived from: https://clinicaltrials.gov/show/NCT02232659

Länk

https://clinicaltrials.gov/show/NCT02232659

Nyckelord

  1. 2016-05-29 2016-05-29 -
Uppladdad den

29 maj 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Life-threatening NCT02232659

    Eligibility Life-threatening NCT02232659

    Criteria
    Beskrivning

    Criteria

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with ife-threatening, irreversible biventricular heart failure (intermacs patient profile classifications 1 - 4)
    Beskrivning

    Biventricular congestive heart failure Life Threatening

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0685095
    UMLS CUI [1,2]
    C2826244
    2. ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [pras]) as determined by the implanting center at time of implant screening assessment.
    Beskrivning

    Heart Transplantation Ineligibility | Medical contraindication Therapeutic immunosuppression Malignant Neoplasms Panel-reactive antibody Elevated

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018823
    UMLS CUI [1,2]
    C1512714
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0021079
    UMLS CUI [2,3]
    C0006826
    UMLS CUI [2,4]
    C1141951
    UMLS CUI [2,5]
    C3163633
    3. on optimal medical management and failing to respond or failing dt vad therapy (continuing to decline)
    Beskrivning

    Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3844738
    UMLS CUI [2,1]
    C0085842
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C0231175
    4. ambulatory without assistance
    Beskrivning

    Ambulate | Helping Behavior

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C4036205
    UMLS CUI [2]
    C0018896
    5. patients between 19 and 75 years of age
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    6. patients with body surface area (bsa) of ≥ 1.7m2
    Beskrivning

    Body Surface Area

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005902
    7. sternum to t10 distance > 10cm or adequate room in chest as determined by 3-d imaging assessment or by other standard clinical assessments
    Beskrivning

    Distance Sternum T10 | Chest Space Adequate | Three-Dimensional Imaging Assessment

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012751
    UMLS CUI [1,2]
    C0038293
    UMLS CUI [1,3]
    C0223341
    UMLS CUI [2,1]
    C0817096
    UMLS CUI [2,2]
    C1883067
    UMLS CUI [2,3]
    C0205411
    UMLS CUI [3,1]
    C0887832
    UMLS CUI [3,2]
    C1516048
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. cardiac transplant-eligible patients
    Beskrivning

    Heart Transplantation Patients eligible

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018823
    UMLS CUI [1,2]
    C0030705
    UMLS CUI [1,3]
    C1548635
    2. patients who cannot be adequately anticoagulated on the tah-t
    Beskrivning

    ANTICOAGULATED STATE | Temporary artificial heart

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0741134
    UMLS CUI [2]
    C0182433
    3. patients with insufficient space in the chest
    Beskrivning

    Chest Space Insufficient

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0817096
    UMLS CUI [1,2]
    C1883067
    UMLS CUI [1,3]
    C0231180
    4. patients on ecmo support
    Beskrivning

    Cardiac support using ECMO

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0397132
    5. patients with cirrhosis (evidenced by ultrasound, ct scan, or positive biopsy)
    Beskrivning

    Liver Cirrhosis | Ultrasonics (sound) | X-Ray Computed Tomography | Biopsy Positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023890
    UMLS CUI [2]
    C1456803
    UMLS CUI [3]
    C0040405
    UMLS CUI [4,1]
    C0005558
    UMLS CUI [4,2]
    C1446409
    6. patients with acute or chronic renal dysfunction (per intermacs ae definitions)
    Beskrivning

    Renal dysfunction | Adverse event Definition

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3279454
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C1704788
    7. patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
    Beskrivning

    Cardiac cachexia | Prealbumin measurement | Fragility | Catabolic Process Imbalance | Anabolism Imbalance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0562491
    UMLS CUI [2]
    C0337441
    UMLS CUI [3]
    C0302113
    UMLS CUI [4,1]
    C1516314
    UMLS CUI [4,2]
    C1397014
    UMLS CUI [5,1]
    C0220781
    UMLS CUI [5,2]
    C1397014
    8. patients with a comorbidity that has a poor prognosis of survival beyond six months
    Beskrivning

    Comorbidity Continuance of life Prognosis bad

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0038952
    UMLS CUI [1,3]
    C0278252
    9. patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the principal investigator)
    Beskrivning

    SOCIAL SUPPORT POOR | Compliance behavior Limited

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0748876
    UMLS CUI [2,1]
    C1321605
    UMLS CUI [2,2]
    C0439801
    secondary arm
    Beskrivning

    Protocol Treatment Arm Secondary

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C0175668
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients who are not eligible to participate in the primary arm
    Beskrivning

    Ineligibility Participation Protocol Treatment Arm Primary

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1512714
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C1522541
    UMLS CUI [1,4]
    C0205225
    2. patients with life-threatening, irreversible biventricular heart failure (intermacs patient profile classifications 1 - 7)
    Beskrivning

    Biventricular congestive heart failure Life Threatening

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0685095
    UMLS CUI [1,2]
    C2826244
    3. ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
    Beskrivning

    Heart Transplantation Ineligibility

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018823
    UMLS CUI [1,2]
    C1512714
    4. on optimal medical management and failing to respond or failing dt vad therapy (continuing to decline)
    Beskrivning

    Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3844738
    UMLS CUI [2,1]
    C0085842
    UMLS CUI [2,2]
    C0087111
    UMLS CUI [2,3]
    C0231175
    5. patients 19 years of age or older
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    6. sternum to t10 distance > 10cm or adequate room in chest as determined by 3-d imaging assessment or by other standard clinical assessments
    Beskrivning

    Distance Sternum T10 | Chest Space Adequate | Three-Dimensional Imaging Assessment

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012751
    UMLS CUI [1,2]
    C0038293
    UMLS CUI [1,3]
    C0223341
    UMLS CUI [2,1]
    C0817096
    UMLS CUI [2,2]
    C1883067
    UMLS CUI [2,3]
    C0205411
    UMLS CUI [3,1]
    C0887832
    UMLS CUI [3,2]
    C1516048
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients who are less than 19 years old
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. cardiac transplant-eligible patients
    Beskrivning

    Heart Transplantation Patients eligible

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018823
    UMLS CUI [1,2]
    C0030705
    UMLS CUI [1,3]
    C1548635
    3. patients with cirrhosis (evidenced by ultrasound, ct scan, or positive biopsy)
    Beskrivning

    Liver Cirrhosis | Ultrasonics (sound) | X-Ray Computed Tomography | Biopsy Positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023890
    UMLS CUI [2]
    C1456803
    UMLS CUI [3]
    C0040405
    UMLS CUI [4,1]
    C0005558
    UMLS CUI [4,2]
    C1446409
    4. patients with chronic renal dysfunction (per intermacs ae definitions)
    Beskrivning

    Renal dysfunction chronic | Adverse event Definition

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3279454
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C1704788
    5. patients with insufficient space in the chest
    Beskrivning

    Chest Space Insufficient

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0817096
    UMLS CUI [1,2]
    C1883067
    UMLS CUI [1,3]
    C0231180
    6. patients who cannot be adequately anticoagulated on the tah-t
    Beskrivning

    ANTICOAGULATED STATE | Temporary artificial heart

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0741134
    UMLS CUI [2]
    C0182433
    7. patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the principal investigator)
    Beskrivning

    SOCIAL SUPPORT POOR | Compliance behavior Limited

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0748876
    UMLS CUI [2,1]
    C1321605
    UMLS CUI [2,2]
    C0439801

    Similar models

    Eligibility Life-threatening NCT02232659

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Item Group
    C1512693 (UMLS CUI)
    Biventricular congestive heart failure Life Threatening
    Item
    1. patients with ife-threatening, irreversible biventricular heart failure (intermacs patient profile classifications 1 - 4)
    boolean
    C0685095 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    Heart Transplantation Ineligibility | Medical contraindication Therapeutic immunosuppression Malignant Neoplasms Panel-reactive antibody Elevated
    Item
    2. ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [pras]) as determined by the implanting center at time of implant screening assessment.
    boolean
    C0018823 (UMLS CUI [1,1])
    C1512714 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [2,1])
    C0021079 (UMLS CUI [2,2])
    C0006826 (UMLS CUI [2,3])
    C1141951 (UMLS CUI [2,4])
    C3163633 (UMLS CUI [2,5])
    Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed
    Item
    3. on optimal medical management and failing to respond or failing dt vad therapy (continuing to decline)
    boolean
    C0087111 (UMLS CUI [1,1])
    C3844738 (UMLS CUI [1,2])
    C0085842 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    Ambulate | Helping Behavior
    Item
    4. ambulatory without assistance
    boolean
    C4036205 (UMLS CUI [1])
    C0018896 (UMLS CUI [2])
    Age
    Item
    5. patients between 19 and 75 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Body Surface Area
    Item
    6. patients with body surface area (bsa) of ≥ 1.7m2
    boolean
    C0005902 (UMLS CUI [1])
    Distance Sternum T10 | Chest Space Adequate | Three-Dimensional Imaging Assessment
    Item
    7. sternum to t10 distance > 10cm or adequate room in chest as determined by 3-d imaging assessment or by other standard clinical assessments
    boolean
    C0012751 (UMLS CUI [1,1])
    C0038293 (UMLS CUI [1,2])
    C0223341 (UMLS CUI [1,3])
    C0817096 (UMLS CUI [2,1])
    C1883067 (UMLS CUI [2,2])
    C0205411 (UMLS CUI [2,3])
    C0887832 (UMLS CUI [3,1])
    C1516048 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Heart Transplantation Patients eligible
    Item
    1. cardiac transplant-eligible patients
    boolean
    C0018823 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    C1548635 (UMLS CUI [1,3])
    ANTICOAGULATED STATE | Temporary artificial heart
    Item
    2. patients who cannot be adequately anticoagulated on the tah-t
    boolean
    C0741134 (UMLS CUI [1])
    C0182433 (UMLS CUI [2])
    Chest Space Insufficient
    Item
    3. patients with insufficient space in the chest
    boolean
    C0817096 (UMLS CUI [1,1])
    C1883067 (UMLS CUI [1,2])
    C0231180 (UMLS CUI [1,3])
    Cardiac support using ECMO
    Item
    4. patients on ecmo support
    boolean
    C0397132 (UMLS CUI [1])
    Liver Cirrhosis | Ultrasonics (sound) | X-Ray Computed Tomography | Biopsy Positive
    Item
    5. patients with cirrhosis (evidenced by ultrasound, ct scan, or positive biopsy)
    boolean
    C0023890 (UMLS CUI [1])
    C1456803 (UMLS CUI [2])
    C0040405 (UMLS CUI [3])
    C0005558 (UMLS CUI [4,1])
    C1446409 (UMLS CUI [4,2])
    Renal dysfunction | Adverse event Definition
    Item
    6. patients with acute or chronic renal dysfunction (per intermacs ae definitions)
    boolean
    C3279454 (UMLS CUI [1])
    C0877248 (UMLS CUI [2,1])
    C1704788 (UMLS CUI [2,2])
    Cardiac cachexia | Prealbumin measurement | Fragility | Catabolic Process Imbalance | Anabolism Imbalance
    Item
    7. patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
    boolean
    C0562491 (UMLS CUI [1])
    C0337441 (UMLS CUI [2])
    C0302113 (UMLS CUI [3])
    C1516314 (UMLS CUI [4,1])
    C1397014 (UMLS CUI [4,2])
    C0220781 (UMLS CUI [5,1])
    C1397014 (UMLS CUI [5,2])
    Comorbidity Continuance of life Prognosis bad
    Item
    8. patients with a comorbidity that has a poor prognosis of survival beyond six months
    boolean
    C0009488 (UMLS CUI [1,1])
    C0038952 (UMLS CUI [1,2])
    C0278252 (UMLS CUI [1,3])
    SOCIAL SUPPORT POOR | Compliance behavior Limited
    Item
    9. patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the principal investigator)
    boolean
    C0748876 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    Protocol Treatment Arm Secondary
    Item
    secondary arm
    boolean
    C1522541 (UMLS CUI [1,1])
    C0175668 (UMLS CUI [1,2])
    Item Group
    C1512693 (UMLS CUI)
    Ineligibility Participation Protocol Treatment Arm Primary
    Item
    1. patients who are not eligible to participate in the primary arm
    boolean
    C1512714 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C1522541 (UMLS CUI [1,3])
    C0205225 (UMLS CUI [1,4])
    Biventricular congestive heart failure Life Threatening
    Item
    2. patients with life-threatening, irreversible biventricular heart failure (intermacs patient profile classifications 1 - 7)
    boolean
    C0685095 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    Heart Transplantation Ineligibility
    Item
    3. ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
    boolean
    C0018823 (UMLS CUI [1,1])
    C1512714 (UMLS CUI [1,2])
    Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed
    Item
    4. on optimal medical management and failing to respond or failing dt vad therapy (continuing to decline)
    boolean
    C0087111 (UMLS CUI [1,1])
    C3844738 (UMLS CUI [1,2])
    C0085842 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    Age
    Item
    5. patients 19 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Distance Sternum T10 | Chest Space Adequate | Three-Dimensional Imaging Assessment
    Item
    6. sternum to t10 distance > 10cm or adequate room in chest as determined by 3-d imaging assessment or by other standard clinical assessments
    boolean
    C0012751 (UMLS CUI [1,1])
    C0038293 (UMLS CUI [1,2])
    C0223341 (UMLS CUI [1,3])
    C0817096 (UMLS CUI [2,1])
    C1883067 (UMLS CUI [2,2])
    C0205411 (UMLS CUI [2,3])
    C0887832 (UMLS CUI [3,1])
    C1516048 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Age
    Item
    1. patients who are less than 19 years old
    boolean
    C0001779 (UMLS CUI [1])
    Heart Transplantation Patients eligible
    Item
    2. cardiac transplant-eligible patients
    boolean
    C0018823 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    C1548635 (UMLS CUI [1,3])
    Liver Cirrhosis | Ultrasonics (sound) | X-Ray Computed Tomography | Biopsy Positive
    Item
    3. patients with cirrhosis (evidenced by ultrasound, ct scan, or positive biopsy)
    boolean
    C0023890 (UMLS CUI [1])
    C1456803 (UMLS CUI [2])
    C0040405 (UMLS CUI [3])
    C0005558 (UMLS CUI [4,1])
    C1446409 (UMLS CUI [4,2])
    Renal dysfunction chronic | Adverse event Definition
    Item
    4. patients with chronic renal dysfunction (per intermacs ae definitions)
    boolean
    C3279454 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [2,1])
    C1704788 (UMLS CUI [2,2])
    Chest Space Insufficient
    Item
    5. patients with insufficient space in the chest
    boolean
    C0817096 (UMLS CUI [1,1])
    C1883067 (UMLS CUI [1,2])
    C0231180 (UMLS CUI [1,3])
    ANTICOAGULATED STATE | Temporary artificial heart
    Item
    6. patients who cannot be adequately anticoagulated on the tah-t
    boolean
    C0741134 (UMLS CUI [1])
    C0182433 (UMLS CUI [2])
    SOCIAL SUPPORT POOR | Compliance behavior Limited
    Item
    7. patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the principal investigator)
    boolean
    C0748876 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])

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