ID

41175

Description

Safety and Efficacy of Cryothermia to Treat Longstanding Persistent Atrial Fibrillation (AF); ODM derived from: https://clinicaltrials.gov/show/NCT01558635

Link

https://clinicaltrials.gov/show/NCT01558635

Keywords

Versions (1)
  1. 7/5/20 7/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Longstanding Persistent Atrial Fibrillation NCT01558635

English

Eligibility Longstanding Persistent Atrial Fibrillation NCT01558635

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a documented history of longstanding persistent af as defined by the hrs/ehra/ecas guidelines
Description

Persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
patients should have a concomitant indication (other than af) for open-heart surgery for mitral valve repair or replacement (bioprosthesis)
Description

Indication Open heart surgery | Mitral valvuloplasty | Repair of mitral valve with prosthesis

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0189745
UMLS CUI [2]
C0396849
UMLS CUI [3]
C0190144
patients should be older than or equal to 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
atrioventricular reentrant tachycardia (avrt)
Description

Atrioventricular re-entrant tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C3264368
nyha class = iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
left ejection fraction of ≤ 30%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery
Description

Patient need for Cardiac Surgery Emergency Situation | Shock, Cardiogenic | Patient need for Redo Open heart surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0018821
UMLS CUI [1,3]
C0013956
UMLS CUI [2]
C0036980
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0439617
UMLS CUI [3,3]
C0189745
previous atrial fibrillation ablation, av-nodal ablation, or surgical maze procedure
Description

Catheter ablation for atrial fibrillation | Ablation of Cardiac Atrioventricular Node | Maze Procedure

Data type

boolean

Alias
UMLS CUI [1]
C2702800
UMLS CUI [2]
C3275044
UMLS CUI [3]
C1260336
contraindication for anticoagulation therapy
Description

Medical contraindication Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
left atrial diameter > 7.0 cm
Description

Left atrium Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
preoperative need for intra-aortic balloon pump or intravenous inotropes
Description

Patient need for Intra-aortic balloon pump Preoperative | Patient need for Inotropic agent Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0702122
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0304509
UMLS CUI [2,3]
C1522726
renal failure requiring dialysis or hepatic failure
Description

Kidney Failure Requirement Dialysis | Liver Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2]
C0085605
life expectancy of less than one year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pregnancy or desire to be pregnant within 12 months of the study treatment
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
current diagnosis of active systemic infection
Description

Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
documented mi 6 weeks prior to study enrollment
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
Back to the top of the page

Similar models

Eligibility Longstanding Persistent Atrial Fibrillation NCT01558635

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Persistent atrial fibrillation
Item
patients must have a documented history of longstanding persistent af as defined by the hrs/ehra/ecas guidelines
boolean
C2585653 (UMLS CUI [1])
Indication Open heart surgery | Mitral valvuloplasty | Repair of mitral valve with prosthesis
Item
patients should have a concomitant indication (other than af) for open-heart surgery for mitral valve repair or replacement (bioprosthesis)
boolean
C3146298 (UMLS CUI [1,1])
C0189745 (UMLS CUI [1,2])
C0396849 (UMLS CUI [2])
C0190144 (UMLS CUI [3])
Age
Item
patients should be older than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrioventricular re-entrant tachycardia
Item
atrioventricular reentrant tachycardia (avrt)
boolean
C3264368 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class = iv
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ejection fraction of ≤ 30%
boolean
C0428772 (UMLS CUI [1])
Patient need for Cardiac Surgery Emergency Situation | Shock, Cardiogenic | Patient need for Redo Open heart surgery
Item
need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery
boolean
C0686904 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C0013956 (UMLS CUI [1,3])
C0036980 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0439617 (UMLS CUI [3,2])
C0189745 (UMLS CUI [3,3])
Catheter ablation for atrial fibrillation | Ablation of Cardiac Atrioventricular Node | Maze Procedure
Item
previous atrial fibrillation ablation, av-nodal ablation, or surgical maze procedure
boolean
C2702800 (UMLS CUI [1])
C3275044 (UMLS CUI [2])
C1260336 (UMLS CUI [3])
Medical contraindication Anticoagulation Therapy
Item
contraindication for anticoagulation therapy
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Left atrium Diameter
Item
left atrial diameter > 7.0 cm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Patient need for Intra-aortic balloon pump Preoperative | Patient need for Inotropic agent Intravenous
Item
preoperative need for intra-aortic balloon pump or intravenous inotropes
boolean
C0686904 (UMLS CUI [1,1])
C0702122 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0304509 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
Kidney Failure Requirement Dialysis | Liver Failure
Item
renal failure requiring dialysis or hepatic failure
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0085605 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of less than one year
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnancy or desire to be pregnant within 12 months of the study treatment
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Sepsis
Item
current diagnosis of active systemic infection
boolean
C0243026 (UMLS CUI [1])
Myocardial Infarction
Item
documented mi 6 weeks prior to study enrollment
boolean
C0027051 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial