ID

25785

Beschreibung

AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00560885

Link

https://clinicaltrials.gov/show/NCT00560885

Stichworte

Versionen (1)
  1. 19.09.17 19.09.17 -
Hochgeladen am

19. September 2017

DOI

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Eligibility Atrial Fibrillation NCT00560885

Englisch

Eligibility Atrial Fibrillation NCT00560885

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is greater than or equal to 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. subject has history of permanent atrial fibrillation as defined by the acc/aha/esc guidelines
Beschreibung

Permanent atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C2586056
3. subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
Beschreibung

Cardiac Surgery procedures On pump elective Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C3842462
UMLS CUI [1,3]
C0439608
UMLS CUI [1,4]
C0205539
mitral valve repair or replacement
Beschreibung

Mitral valvuloplasty | Replacement of mitral valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0396849
UMLS CUI [2]
C0026268
aortic valve repair or replacement
Beschreibung

Valvuloplasty of aortic valve | Replacement of aortic valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0396949
UMLS CUI [2]
C0003506
tricuspid valve repair or replacement
Beschreibung

Repair of tricuspid valve | Replacement of tricuspid valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0396899
UMLS CUI [2]
C0190119
coronary artery bypass procedures
Beschreibung

Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0010055
atrial septal defect repair
Beschreibung

Atrioseptoplasty

Datentyp

boolean

Alias
UMLS CUI [1]
C0189965
patent foramen ovale closure
Beschreibung

Closure of patent foramen ovale

Datentyp

boolean

Alias
UMLS CUI [1]
C0189967
4. subject's left ventricular ejection fraction ≥ 30%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
5. subject is able and willing to provide written informed consent and comply with study requirements
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
6. subject has life expectancy of at least 1 year
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. stand alone af without indication(s) for concomitant cabg, valve surgery, asd repair, or pfo closure
Beschreibung

Atrial Fibrillation Alone | Indication Absent Coronary Artery Bypass Surgery | Indication Absent Heart Valves Operative Surgical Procedures | Indication Absent Atrioseptoplasty | Indication Absent Closure of patent foramen ovale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0010055
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0018826
UMLS CUI [3,4]
C0543467
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0189965
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0189967
2. previous cardiac ablation including catheter ablation, av-nodal ablation, or surgical maze procedure
Beschreibung

Cardiac ablation | Ablation of Cardiac Atrioventricular Node | Surgical Maze Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0162563
UMLS CUI [2]
C3275044
UMLS CUI [3]
C3272262
3. wolff-parkinson-white syndrome
Beschreibung

Wolff-Parkinson-White Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0043202
4. prior cardiac surgery (redo)
Beschreibung

Cardiac Surgery procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0018821
5. class iv nyha heart failure symptoms
Beschreibung

Heart failure Symptoms New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
6. prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
Beschreibung

Cerebrovascular accident | Neurologic Deficits Residual

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0521654
UMLS CUI [2,2]
C1609982
7. documented mi within 6 weeks prior to study enrollment
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
8. need for emergent cardiac surgery (i.e. cardiogenic shock)
Beschreibung

Cardiac Surgery Emergency Patient need for | Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0036980
9. known carotid artery stenosis greater than 80%
Beschreibung

Carotid Stenosis Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007282
UMLS CUI [1,2]
C0439165
10. la size greater than or equal to 8cm
Beschreibung

Left atrium Size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
11. current diagnosis of active systemic infection
Beschreibung

Sepsis

Datentyp

boolean

Alias
UMLS CUI [1]
C0243026
12. severe peripheral arterial occlusive disease defined as claudication with minimal exertion
Beschreibung

Peripheral arterial occlusive disease Severe | Claudication Exertion Minimal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306889
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1456822
UMLS CUI [2,2]
C0015264
UMLS CUI [2,3]
C0547040
13. pregnancy or desire to get pregnant within 12-months of the study enrollment
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
14. preoperative need for an intra-aortic balloon pump or intravenous inotropes
Beschreibung

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

Datentyp

boolean

Alias
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]
C0445204
UMLS CUI [2,4]
C0686904
15. 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
16. requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Beschreibung

Ventricular arrhythmia | Anti-Arrhythmia Agents Patient need for

Datentyp

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0686904
17. therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
Beschreibung

Therapeutic procedure Resulting in Impaired tissue integrity | Radiotherapy to thorax | Chemotherapy | Steroids Oral Long-term | Injection of steroid Long-term | Connective Tissue Diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0150085
UMLS CUI [2]
C4038705
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C0443252
UMLS CUI [5,1]
C1261311
UMLS CUI [5,2]
C0443252
UMLS CUI [6]
C0009782
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00560885

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subject is greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Permanent atrial fibrillation
Item
2. subject has history of permanent atrial fibrillation as defined by the acc/aha/esc guidelines
boolean
C2586056 (UMLS CUI [1])
Cardiac Surgery procedures On pump elective Scheduled
Item
3. subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
boolean
C0018821 (UMLS CUI [1,1])
C3842462 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
Mitral valvuloplasty | Replacement of mitral valve
Item
mitral valve repair or replacement
boolean
C0396849 (UMLS CUI [1])
C0026268 (UMLS CUI [2])
Valvuloplasty of aortic valve | Replacement of aortic valve
Item
aortic valve repair or replacement
boolean
C0396949 (UMLS CUI [1])
C0003506 (UMLS CUI [2])
Repair of tricuspid valve | Replacement of tricuspid valve
Item
tricuspid valve repair or replacement
boolean
C0396899 (UMLS CUI [1])
C0190119 (UMLS CUI [2])
Coronary Artery Bypass Surgery
Item
coronary artery bypass procedures
boolean
C0010055 (UMLS CUI [1])
Atrioseptoplasty
Item
atrial septal defect repair
boolean
C0189965 (UMLS CUI [1])
Closure of patent foramen ovale
Item
patent foramen ovale closure
boolean
C0189967 (UMLS CUI [1])
Left ventricular ejection fraction
Item
4. subject's left ventricular ejection fraction ≥ 30%
boolean
C0428772 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
5. subject is able and willing to provide written informed consent and comply with study requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Life Expectancy
Item
6. subject has life expectancy of at least 1 year
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Alone | Indication Absent Coronary Artery Bypass Surgery | Indication Absent Heart Valves Operative Surgical Procedures | Indication Absent Atrioseptoplasty | Indication Absent Closure of patent foramen ovale
Item
1. stand alone af without indication(s) for concomitant cabg, valve surgery, asd repair, or pfo closure
boolean
C0004238 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0010055 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0018826 (UMLS CUI [3,3])
C0543467 (UMLS CUI [3,4])
C3146298 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0189965 (UMLS CUI [4,3])
C3146298 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0189967 (UMLS CUI [5,3])
Cardiac ablation | Ablation of Cardiac Atrioventricular Node | Surgical Maze Procedure
Item
2. previous cardiac ablation including catheter ablation, av-nodal ablation, or surgical maze procedure
boolean
C0162563 (UMLS CUI [1])
C3275044 (UMLS CUI [2])
C3272262 (UMLS CUI [3])
Wolff-Parkinson-White Syndrome
Item
3. wolff-parkinson-white syndrome
boolean
C0043202 (UMLS CUI [1])
Cardiac Surgery procedures
Item
4. prior cardiac surgery (redo)
boolean
C0018821 (UMLS CUI [1])
Heart failure Symptoms New York Heart Association Classification
Item
5. class iv nyha heart failure symptoms
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Cerebrovascular accident | Neurologic Deficits Residual
Item
6. prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
boolean
C0038454 (UMLS CUI [1])
C0521654 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
Myocardial Infarction
Item
7. documented mi within 6 weeks prior to study enrollment
boolean
C0027051 (UMLS CUI [1])
Cardiac Surgery Emergency Patient need for | Shock, Cardiogenic
Item
8. need for emergent cardiac surgery (i.e. cardiogenic shock)
boolean
C0018821 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0036980 (UMLS CUI [2])
Carotid Stenosis Percentage
Item
9. known carotid artery stenosis greater than 80%
boolean
C0007282 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Left atrium Size
Item
10. la size greater than or equal to 8cm
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Sepsis
Item
11. current diagnosis of active systemic infection
boolean
C0243026 (UMLS CUI [1])
Peripheral arterial occlusive disease Severe | Claudication Exertion Minimal
Item
12. severe peripheral arterial occlusive disease defined as claudication with minimal exertion
boolean
C1306889 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1456822 (UMLS CUI [2,1])
C0015264 (UMLS CUI [2,2])
C0547040 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
13. pregnancy or desire to get pregnant within 12-months of the study enrollment
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Intra-aortic balloon pump Preoperative Patient need for | Inotropic agent Intravenous Preoperative Patient need for
Item
14. preoperative need for an intra-aortic balloon pump or intravenous inotropes
boolean
C0702122 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0304509 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C0686904 (UMLS CUI [2,4])
Kidney Failure Requirement Dialysis | Liver Failure
Item
15. 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])
Ventricular arrhythmia | Anti-Arrhythmia Agents Patient need for
Item
16. requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
boolean
C0085612 (UMLS CUI [1])
C0003195 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Therapeutic procedure Resulting in Impaired tissue integrity | Radiotherapy to thorax | Chemotherapy | Steroids Oral Long-term | Injection of steroid Long-term | Connective Tissue Diseases
Item
17. therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
boolean
C0087111 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0150085 (UMLS CUI [1,3])
C4038705 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0038317 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
C1261311 (UMLS CUI [5,1])
C0443252 (UMLS CUI [5,2])
C0009782 (UMLS CUI [6])
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