ID

16266

Descrizione

Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00281073

collegamento

https://clinicaltrials.gov/show/NCT00281073

Keywords

versioni (1)
  1. 08/07/16 08/07/16 -
Caricato su

8 luglio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00281073

Inglese

Eligibility Atrial Fibrillation NCT00281073

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for the phase i component
Descrizione

inclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1512693
1. patients with spontaneous af
Descrizione

spontaneous af

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0235480
2. patients with or without structural heart disease.
Descrizione

structural heart disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1290384
3. men or women aged 18 years or older.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
4. patients undergoing an invasive catheterization procedure including right heart catheterization.
Descrizione

invasive catheterization procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018795
5. patients who give an informed consent for participation in the study.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
Descrizione

intracardiac thrombi

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0876998
7. patients who have undergone a trans-esophageal echocardiogram within the last 48 hours.
Descrizione

trans-esophageal echocardiogram

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0206054
inclusion criteria for the phase ii component
Descrizione

inclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1512693
1. patients with spontaneous af
Descrizione

spontaneous af

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0235480
2. patients with or without structural heart disease.
Descrizione

structural heart disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1290384
3. men or women aged 18 years or older.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
4. patients undergoing an invasive catheterization procedure including right heart catheterization.
Descrizione

invasive catheterization procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018795
5. patients who give an informed consent for participation in the study.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
Descrizione

intracardiac thrombi

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0876998
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria for the phase ii component
Descrizione

exclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
1. patients anticoagulated for > 7 days.
Descrizione

Anticoagulation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0449867
2. patients who have had a cardioembolic event within the last 1-month.
Descrizione

cardioembolic event

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1531624
3. patients requiring urgent cardioversion due to hemodynamic instability.
Descrizione

cardioversion due to hemodynamic instability

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013778
UMLS CUI [2]
C0948268
4. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
Descrizione

Technical feasibility

Tipo di dati

boolean

5. patients with contraindications for warfarin.
Descrizione

contraindications for warfarin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278473
6. women of child bearing potential, in whom pregnancy cannot be excluded.
Descrizione

women of child bearing potential

Tipo di dati

text

Alias
UMLS CUI [1]
C0425965
7. patients who need anticoagulation withdrawn due to an elective procedure
Descrizione

anticoagulation

Tipo di dati

text

Alias
UMLS CUI [1]
C0449867
8. patients with any medical condition or social circumstance, which in the opinion of the investigator would make the patient's successful completion of the study doubtful.
Descrizione

medical condition or social circumstance

Tipo di dati

text

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0037431
exclusion criteria for the phase i component
Descrizione

exclusion criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
1. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
Descrizione

Technical feasibility

Tipo di dati

boolean

2. women of child bearing potential, in whom pregnancy cannot be excluded.
Descrizione

women of child bearing potential

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0425965
3. patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
Descrizione

medical condition or social circumstance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0037431
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Similar models

Eligibility Atrial Fibrillation NCT00281073

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
inclusion criteria
Item
inclusion criteria for the phase i component
boolean
C1512693 (UMLS CUI [1])
spontaneous af
Item
1. patients with spontaneous af
boolean
C0235480 (UMLS CUI [1])
structural heart disease
Item
2. patients with or without structural heart disease.
boolean
C1290384 (UMLS CUI [1])
Age
Item
3. men or women aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
invasive catheterization procedure
Item
4. patients undergoing an invasive catheterization procedure including right heart catheterization.
boolean
C0018795 (UMLS CUI [1])
informed consent
Item
5. patients who give an informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
intracardiac thrombi
Item
6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
boolean
C0876998 (UMLS CUI [1])
trans-esophageal echocardiogram
Item
7. patients who have undergone a trans-esophageal echocardiogram within the last 48 hours.
boolean
C0206054 (UMLS CUI [1])
inclusion criteria
Item
inclusion criteria for the phase ii component
boolean
C1512693 (UMLS CUI [1])
spontaneous af
Item
1. patients with spontaneous af
boolean
C0235480 (UMLS CUI [1])
structural heart disease
Item
2. patients with or without structural heart disease.
boolean
C1290384 (UMLS CUI [1])
Age
Item
3. men or women aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
invasive catheterization procedure
Item
4. patients undergoing an invasive catheterization procedure including right heart catheterization.
boolean
C0018795 (UMLS CUI [1])
informed consent
Item
5. patients who give an informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
intracardiac thrombi
Item
6. patients who have undergone a trans-thoracic echocardiogram within the last 14 days showing absence of intracardiac thrombi.
boolean
C0876998 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
exclusion criteria for the phase ii component
boolean
C0680251 (UMLS CUI [1])
Anticoagulation
Item
1. patients anticoagulated for > 7 days.
boolean
C0449867 (UMLS CUI [1])
cardioembolic event
Item
2. patients who have had a cardioembolic event within the last 1-month.
boolean
C1531624 (UMLS CUI [1])
cardioversion due to hemodynamic instability
Item
3. patients requiring urgent cardioversion due to hemodynamic instability.
boolean
C0013778 (UMLS CUI [1])
C0948268 (UMLS CUI [2])
Technical feasibility
Item
4. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
boolean
contraindications for warfarin
Item
5. patients with contraindications for warfarin.
boolean
C1278473 (UMLS CUI [1])
women of child bearing potential
Item
6. women of child bearing potential, in whom pregnancy cannot be excluded.
text
C0425965 (UMLS CUI [1])
anticoagulation
Item
7. patients who need anticoagulation withdrawn due to an elective procedure
text
C0449867 (UMLS CUI [1])
medical condition or social circumstance
Item
8. patients with any medical condition or social circumstance, which in the opinion of the investigator would make the patient's successful completion of the study doubtful.
text
C0009488 (UMLS CUI [1])
C0037431 (UMLS CUI [2])
exclusion criteria
Item
exclusion criteria for the phase i component
boolean
C0680251 (UMLS CUI [1])
Technical feasibility
Item
1. patients in whom placement of an ice catheter for adequate atrial visualization is technically not feasible.
boolean
women of child bearing potential
Item
2. women of child bearing potential, in whom pregnancy cannot be excluded.
boolean
C0425965 (UMLS CUI [1])
medical condition or social circumstance
Item
3. patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
boolean
C0009488 (UMLS CUI [1])
C0037431 (UMLS CUI [2])
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