ID

41175

Beschreibung

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

Stichworte

Versionen (1)
  1. 05.07.20 05.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Juli 2020

DOI

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Eligibility Longstanding Persistent Atrial Fibrillation NCT01558635

Englisch

Eligibility Longstanding Persistent Atrial Fibrillation NCT01558635

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Persistent atrial fibrillation

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
atrioventricular reentrant tachycardia (avrt)
Beschreibung

Atrioventricular re-entrant tachycardia

Datentyp

boolean

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

New York Heart Association Classification

Datentyp

boolean

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

Left ventricular ejection fraction

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

Medical contraindication Anticoagulation Therapy

Datentyp

boolean

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

Left atrium Diameter

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Kidney Failure Requirement Dialysis | Liver Failure

Datentyp

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
Beschreibung

Life Expectancy

Datentyp

boolean

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

Pregnancy | Pregnancy, Planned

Datentyp

boolean

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

Sepsis

Datentyp

boolean

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

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
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Ähnliche Modelle

Eligibility Longstanding Persistent Atrial Fibrillation NCT01558635

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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