ID

24160

Description

Safety and Performance Evaluation of CircuLite Synergy; ODM derived from: https://clinicaltrials.gov/show/NCT00878527

Link

https://clinicaltrials.gov/show/NCT00878527

Keywords

  1. 7/26/17 7/26/17 -
Uploaded on

July 26, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT00878527

Eligibility Heart Failure NCT00878527

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
maximum tolerable medical therapy including ace inhibitors and beta blockers
Description

Therapeutic procedure Maximum Tolerable | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C4053931
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0304516
nyha class iii or iv despite maximal tolerable medical therapy
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
ambulatory (inpatient or outpatient)
Description

Inpatient Ambulatory | Outpatient Ambulatory

Data type

boolean

Alias
UMLS CUI [1,1]
C0021562
UMLS CUI [1,2]
C0439841
UMLS CUI [2,1]
C0029921
UMLS CUI [2,2]
C0439841
patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant)
Description

Patient on waiting list Heart Transplantation | Patient Appropriate Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0018823
life expectancy of at least 6 months without full vad support
Description

Life Expectancy | Ventricular assist device Absent

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0085842
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age >75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
exercise tolerance limited by factors other than heart failure
Description

Exercise Tolerance Limited Independent of Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0162521
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0332291
UMLS CUI [1,4]
C0018801
presence of intra-atrial thrombus
Description

Thrombus Atrial

Data type

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0018792
clinically significant right heart failure
Description

Heart Failure, Right-Sided

Data type

boolean

Alias
UMLS CUI [1]
C0235527
serum creatinine >/= 2.5 mg/dl or any dialysis in previous 3 months
Description

Creatinine measurement, serum | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0011946
evidence of intrinsic hepatic disease
Description

Liver disease Intrinsic

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205102
previous episode of resuscitated sudden death without subsequent treatment with aicd
Description

Sudden death Resuscitation Episode of | Automatic Implantable Cardioverter-Defibrillators Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0011071
UMLS CUI [1,2]
C0035273
UMLS CUI [1,3]
C0332189
UMLS CUI [2,1]
C0972395
UMLS CUI [2,2]
C0332197
subclavian artery stenosis
Description

Subclavian artery stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0038531
low platelet count, inr that cannot be corrected prior to implant or contraindication to anticoagulation
Description

Decreased platelet count | International Normalized Ratio Correction Unsuccessful | Medical contraindication Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392386
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C1947976
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0003281

Similar models

Eligibility Heart Failure NCT00878527

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Maximum Tolerable | Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists
Item
maximum tolerable medical therapy including ace inhibitors and beta blockers
boolean
C0087111 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C4053931 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
New York Heart Association Classification
Item
nyha class iii or iv despite maximal tolerable medical therapy
boolean
C1275491 (UMLS CUI [1])
Inpatient Ambulatory | Outpatient Ambulatory
Item
ambulatory (inpatient or outpatient)
boolean
C0021562 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
C0029921 (UMLS CUI [2,1])
C0439841 (UMLS CUI [2,2])
Patient on waiting list Heart Transplantation | Patient Appropriate Heart Transplantation
Item
patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant)
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0018823 (UMLS CUI [2,3])
Life Expectancy | Ventricular assist device Absent
Item
life expectancy of at least 6 months without full vad support
boolean
C0023671 (UMLS CUI [1])
C0085842 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age >75 years
boolean
C0001779 (UMLS CUI [1])
Exercise Tolerance Limited Independent of Heart failure
Item
exercise tolerance limited by factors other than heart failure
boolean
C0162521 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0332291 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
Thrombus Atrial
Item
presence of intra-atrial thrombus
boolean
C0087086 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
Heart Failure, Right-Sided
Item
clinically significant right heart failure
boolean
C0235527 (UMLS CUI [1])
Creatinine measurement, serum | Dialysis
Item
serum creatinine >/= 2.5 mg/dl or any dialysis in previous 3 months
boolean
C0201976 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Liver disease Intrinsic
Item
evidence of intrinsic hepatic disease
boolean
C0023895 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
Sudden death Resuscitation Episode of | Automatic Implantable Cardioverter-Defibrillators Absent
Item
previous episode of resuscitated sudden death without subsequent treatment with aicd
boolean
C0011071 (UMLS CUI [1,1])
C0035273 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0972395 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Subclavian artery stenosis
Item
subclavian artery stenosis
boolean
C0038531 (UMLS CUI [1])
Decreased platelet count | International Normalized Ratio Correction Unsuccessful | Medical contraindication Anticoagulation Therapy
Item
low platelet count, inr that cannot be corrected prior to implant or contraindication to anticoagulation
boolean
C0392386 (UMLS CUI [1])
C0525032 (UMLS CUI [2,1])
C1947976 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])

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