ID

18835

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00584415

Nyckelord

Versioner (1)
  1. 2016-11-22 2016-11-22 -
Uppladdad den

22 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT00584415

Engelsk

Eligibility Paroxysmal Atrial Fibrillation NCT00584415

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Atrial Fibrillation Episode Quantity

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. left atrial thrombus
Beskrivning

Thrombus of left atrium

Datatyp

boolean

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

Myocardial Infarction

Datatyp

boolean

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

Incision of atrium of heart

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy

Datatyp

boolean

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

Ablation Pulmonary vein

Datatyp

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.
Beskrivning

Ablation | Perforation Occurrence

Datatyp

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.
Beskrivning

Congenital Abnormality Significant Excludes Enrollment | Patient Problem Significant Excludes Enrollment

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

Study Subject Participation Status Unwilling | Follow-up Unavailable

Datatyp

boolean

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

In prison

Datatyp

boolean

Alias
UMLS CUI [1]
C0392751
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Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT00584415

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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