ID

36817

Beschrijving

Prospective, Randomized Comparison of Hybrid Ablation vs. Catheter Ablation (PRHACA); ODM derived from: https://clinicaltrials.gov/show/NCT02344394

Link

https://clinicaltrials.gov/show/NCT02344394

Trefwoorden

Versies (1)
  1. 12-06-19 12-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Persistent Atrial Fibrillation NCT02344394

Engels

Eligibility Persistent Atrial Fibrillation NCT02344394

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
the subject is 18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
left atrium < 6.0 em (trans thoracic echo - tte- parasternal4 chamber view performed within 6 months)
Beschrijving

Left atrium Size Transthoracic echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0430462
history of af for great or equal to 6 months (long standing persistent af)
Beschrijving

Atrial Fibrillation Disease length | Persistent atrial fibrillation Long-term

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0443252
failed or refractory to one aad (class i and/or ill)
Beschrijving

Anti-Arrhythmia Agents Class failed | Anti-Arrhythmia Agents Class Refractory

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C0205269
documentation of persistent af
Beschrijving

Persistent atrial fibrillation Documentation

Datatype

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0920316
provided written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
be eligible for the hybrid procedure
Beschrijving

Eligibility Procedure Hybrid

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0020205
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or planning to become pregnant during study
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
co-morbid medical conditions that limit one year life expectancy
Beschrijving

Comorbidity Limiting Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
previous cardiac surgery
Beschrijving

Cardiac Surgery procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0018821
previous abdominal surgery which will prevent epicardial access
Beschrijving

Operation on abdominal region | Access Epicardial Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0198482
UMLS CUI [2,1]
C0750138
UMLS CUI [2,2]
C0442016
UMLS CUI [2,3]
C0332196
history of pericarditis
Beschrijving

Pericarditis

Datatype

boolean

Alias
UMLS CUI [1]
C0031046
previous cerebrovascular accident (cva), excluding fully resolved tia
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack Resolution Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0007787
UMLS CUI [2,2]
C1514893
UMLS CUI [2,3]
C0332196
patients who have active infection or sepsis
Beschrijving

Communicable Disease | Sepsis

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0243026
patients with esophageal ulcers strictures and varices
Beschrijving

Ulcer of esophagus | Esophageal Stenosis | Esophageal Varices

Datatype

boolean

Alias
UMLS CUI [1]
C0151970
UMLS CUI [2]
C0014866
UMLS CUI [3]
C0014867
patients with renal dysfunction who are not on dialysis (defined as gfr ::5 40)
Beschrijving

Renal dysfunction | Dialysis Absent | Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0017654
patients who are contraindicated for anticoagulants such as heparin and coumadin
Beschrijving

Medical contraindication Anticoagulants | Medical contraindication Heparin | Medical contraindication Coumadin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003280
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0699129
patients who are being treated for ventricular arrhythmias
Beschrijving

Ventricular arrhythmia Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C1522326
patients who have had a previous left atrial catheter ablation for af (does not include ablation for afl or other supraventricular arrhythmias)
Beschrijving

Left atrial catheter ablation Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702799
UMLS CUI [1,2]
C0205091
UMLS CUI [1,3]
C0004238
current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
Beschrijving

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative)
Beschrijving

Incompetence | Guardian Required | Patient Representative Required

Datatype

boolean

Alias
UMLS CUI [1]
C0231189
UMLS CUI [2,1]
C1274041
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C0030701
UMLS CUI [3,2]
C1514873
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Similar models

Eligibility Persistent Atrial Fibrillation NCT02344394

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
the subject is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Left atrium Size Transthoracic echocardiography
Item
left atrium < 6.0 em (trans thoracic echo - tte- parasternal4 chamber view performed within 6 months)
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0430462 (UMLS CUI [1,3])
Atrial Fibrillation Disease length | Persistent atrial fibrillation Long-term
Item
history of af for great or equal to 6 months (long standing persistent af)
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Anti-Arrhythmia Agents Class failed | Anti-Arrhythmia Agents Class Refractory
Item
failed or refractory to one aad (class i and/or ill)
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0003195 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
Persistent atrial fibrillation Documentation
Item
documentation of persistent af
boolean
C2585653 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Informed Consent
Item
provided written informed consent
boolean
C0021430 (UMLS CUI [1])
Eligibility Procedure Hybrid
Item
be eligible for the hybrid procedure
boolean
C1548635 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0020205 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to become pregnant during study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Comorbidity Limiting Life Expectancy
Item
co-morbid medical conditions that limit one year life expectancy
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Cardiac Surgery procedures
Item
previous cardiac surgery
boolean
C0018821 (UMLS CUI [1])
Operation on abdominal region | Access Epicardial Excluded
Item
previous abdominal surgery which will prevent epicardial access
boolean
C0198482 (UMLS CUI [1])
C0750138 (UMLS CUI [2,1])
C0442016 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Pericarditis
Item
history of pericarditis
boolean
C0031046 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack Resolution Excluded
Item
previous cerebrovascular accident (cva), excluding fully resolved tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Communicable Disease | Sepsis
Item
patients who have active infection or sepsis
boolean
C0009450 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Ulcer of esophagus | Esophageal Stenosis | Esophageal Varices
Item
patients with esophageal ulcers strictures and varices
boolean
C0151970 (UMLS CUI [1])
C0014866 (UMLS CUI [2])
C0014867 (UMLS CUI [3])
Renal dysfunction | Dialysis Absent | Glomerular Filtration Rate
Item
patients with renal dysfunction who are not on dialysis (defined as gfr ::5 40)
boolean
C3279454 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0017654 (UMLS CUI [3])
Medical contraindication Anticoagulants | Medical contraindication Heparin | Medical contraindication Coumadin
Item
patients who are contraindicated for anticoagulants such as heparin and coumadin
boolean
C1301624 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0699129 (UMLS CUI [3,2])
Ventricular arrhythmia Treated
Item
patients who are being treated for ventricular arrhythmias
boolean
C0085612 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
Left atrial catheter ablation Atrial Fibrillation
Item
patients who have had a previous left atrial catheter ablation for af (does not include ablation for afl or other supraventricular arrhythmias)
boolean
C2702799 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Incompetence | Guardian Required | Patient Representative Required
Item
not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative)
boolean
C0231189 (UMLS CUI [1])
C1274041 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0030701 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
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