ID

16266

Description

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

Link

https://clinicaltrials.gov/show/NCT00281073

Keywords

Versions (1)
  1. 7/8/16 7/8/16 -
Uploaded on

July 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00281073

English

Eligibility Atrial Fibrillation NCT00281073

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

inclusion criteria

Data type

boolean

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

spontaneous af

Data type

boolean

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

structural heart disease

Data type

boolean

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

Age

Data type

boolean

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

invasive catheterization procedure

Data type

boolean

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

informed consent

Data type

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.
Description

intracardiac thrombi

Data type

boolean

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

trans-esophageal echocardiogram

Data type

boolean

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

inclusion criteria

Data type

boolean

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

spontaneous af

Data type

boolean

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

structural heart disease

Data type

boolean

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

Age

Data type

boolean

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

invasive catheterization procedure

Data type

boolean

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

informed consent

Data type

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.
Description

intracardiac thrombi

Data type

boolean

Alias
UMLS CUI [1]
C0876998
Exclusion Criteria
Description

Exclusion Criteria

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

exclusion criteria

Data type

boolean

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

Anticoagulation

Data type

boolean

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

cardioembolic event

Data type

boolean

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

cardioversion due to hemodynamic instability

Data type

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.
Description

Technical feasibility

Data type

boolean

5. patients with contraindications for warfarin.
Description

contraindications for warfarin

Data type

boolean

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

women of child bearing potential

Data type

text

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

anticoagulation

Data type

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.
Description

medical condition or social circumstance

Data type

text

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

exclusion criteria

Data type

boolean

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

Technical feasibility

Data type

boolean

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

women of child bearing potential

Data type

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
Description

medical condition or social circumstance

Data type

boolean

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

Eligibility Atrial Fibrillation NCT00281073

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