ID

18835

Description

Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00584415

Link

https://clinicaltrials.gov/show/NCT00584415

Keywords

Versions (1)
  1. 11/22/16 11/22/16 -
Uploaded on

November 22, 2016

DOI

To request one please log in.

License

Creative Commons BY 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 Paroxysmal Atrial Fibrillation NCT00584415

English

Eligibility Paroxysmal Atrial Fibrillation NCT00584415

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age greater or equal to 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. at least one documented episode of atrial fibrillation (af) within the previous 6 months.
Description

Atrial Fibrillation Episode Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
3. failure of at least one antiarrhythmic drug (class i or iii) defined as recurrence of af or adverse effect.
Description

Anti-Arrhythmia Agents Class Quantity failed | Recurrent atrial fibrillation | Adverse effects

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
UMLS CUI [2]
C0741282
UMLS CUI [3]
C0879626
4. informed consent obtained.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. left atrial thrombus
Description

Thrombus of left atrium

Data type

boolean

Alias
UMLS CUI [1]
C3532827
2. acute myocardial infarction within eight (8) weeks
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
3. atriotomy within eight (8) weeks
Description

Incision of atrium of heart

Data type

boolean

Alias
UMLS CUI [1]
C0189760
4. decompensated heart failure (unless the af is thought to be a significant etiologic factor and af ablation is clinically indicated)
Description

Decompensated cardiac failure | Atrial Fibrillation Etiology aspects Significant | Indication Atrial Fibrillation ablation

Data type

boolean

Alias
UMLS CUI [1]
C0581377
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0004238
UMLS CUI [3,3]
C0162563
5. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
6. ablation in a pulmonary vein within 4 months.
Description

Ablation Pulmonary vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0034090
7. occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
Description

Ablation | Perforation Occurrence

Data type

boolean

Alias
UMLS CUI [1]
C0547070
UMLS CUI [2,1]
C0549099
UMLS CUI [2,2]
C2745955
8. significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
Description

Congenital Abnormality Significant Excludes Enrollment | Patient Problem Significant Excludes Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C1516879
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C1516879
9. enrolled in an investigational study evaluating another device or drug
Description

Study Subject Participation Status | Investigational New Drug Evaluation | Investigational Medical Device Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0220825
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C0220825
10. unwilling to participate in the study or unavailable for follow-up visits.
Description

Study Subject Participation Status Unwilling | Follow-up Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0686905
11. incarcerated
Description

In prison

Data type

boolean

Alias
UMLS CUI [1]
C0392751
Back to the top of the page

Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT00584415

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age greater or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation Episode Quantity
Item
2. at least one documented episode of atrial fibrillation (af) within the previous 6 months.
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Anti-Arrhythmia Agents Class Quantity failed | Recurrent atrial fibrillation | Adverse effects
Item
3. failure of at least one antiarrhythmic drug (class i or iii) defined as recurrence of af or adverse effect.
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0741282 (UMLS CUI [2])
C0879626 (UMLS CUI [3])
Informed Consent
Item
4. informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thrombus of left atrium
Item
1. left atrial thrombus
boolean
C3532827 (UMLS CUI [1])
Myocardial Infarction
Item
2. acute myocardial infarction within eight (8) weeks
boolean
C0027051 (UMLS CUI [1])
Incision of atrium of heart
Item
3. atriotomy within eight (8) weeks
boolean
C0189760 (UMLS CUI [1])
Decompensated cardiac failure | Atrial Fibrillation Etiology aspects Significant | Indication Atrial Fibrillation ablation
Item
4. decompensated heart failure (unless the af is thought to be a significant etiologic factor and af ablation is clinically indicated)
boolean
C0581377 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
C0162563 (UMLS CUI [3,3])
Pregnancy
Item
5. pregnancy
boolean
C0032961 (UMLS CUI [1])
Ablation Pulmonary vein
Item
6. ablation in a pulmonary vein within 4 months.
boolean
C0547070 (UMLS CUI [1,1])
C0034090 (UMLS CUI [1,2])
Ablation | Perforation Occurrence
Item
7. occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
boolean
C0547070 (UMLS CUI [1])
C0549099 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
Congenital Abnormality Significant Excludes Enrollment | Patient Problem Significant Excludes Enrollment
Item
8. significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
boolean
C0000768 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1516879 (UMLS CUI [1,4])
C1254481 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C1516879 (UMLS CUI [2,4])
Study Subject Participation Status | Investigational New Drug Evaluation | Investigational Medical Device Evaluation
Item
9. enrolled in an investigational study evaluating another device or drug
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0220825 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C0220825 (UMLS CUI [3,2])
Study Subject Participation Status Unwilling | Follow-up Unavailable
Item
10. unwilling to participate in the study or unavailable for follow-up visits.
boolean
C2348568 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
In prison
Item
11. incarcerated
boolean
C0392751 (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