ID

15384

Description

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

Link

https://clinicaltrials.gov/show/NCT02232659

Keywords

Versions (1)
  1. 5/29/16 5/29/16 -
Uploaded on

May 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Life-threatening NCT02232659

English

Eligibility Life-threatening NCT02232659

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

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

Biventricular congestive heart failure Life Threatening

Data type

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.
Description

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

Data type

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)
Description

Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed

Data type

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
Description

Ambulate | Helping Behavior

Data type

boolean

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

Age

Data type

boolean

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

Body Surface Area

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

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

Heart Transplantation Patients eligible

Data type

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
Description

ANTICOAGULATED STATE | Temporary artificial heart

Data type

boolean

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

Chest Space Insufficient

Data type

boolean

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

Cardiac support using ECMO

Data type

boolean

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

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

Data type

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)
Description

Renal dysfunction | Adverse event Definition

Data type

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)
Description

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

Data type

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
Description

Comorbidity Continuance of life Prognosis bad

Data type

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)
Description

SOCIAL SUPPORT POOR | Compliance behavior Limited

Data type

boolean

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

Protocol Treatment Arm Secondary

Data type

boolean

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

Inclusion Criteria

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

Ineligibility Participation Protocol Treatment Arm Primary

Data type

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)
Description

Biventricular congestive heart failure Life Threatening

Data type

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).
Description

Heart Transplantation Ineligibility

Data type

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)
Description

Therapeutic procedure No response | Artificial Ventricle Therapeutic procedure failed

Data type

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
Description

Age

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

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

Age

Data type

boolean

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

Heart Transplantation Patients eligible

Data type

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)
Description

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

Data type

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)
Description

Renal dysfunction chronic | Adverse event Definition

Data type

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
Description

Chest Space Insufficient

Data type

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
Description

ANTICOAGULATED STATE | Temporary artificial heart

Data type

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)
Description

SOCIAL SUPPORT POOR | Compliance behavior Limited

Data type

boolean

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

Eligibility Life-threatening NCT02232659

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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