ID

36817

Description

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

Lien

https://clinicaltrials.gov/show/NCT02344394

Mots-clés

Versions (1)
  1. 12/06/2019 12/06/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

12 juin 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Persistent Atrial Fibrillation NCT02344394

Anglais

Eligibility Persistent Atrial Fibrillation NCT02344394

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

boolean

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

Left atrium Size Transthoracic echocardiography

Type de données

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)
Description

Atrial Fibrillation Disease length | Persistent atrial fibrillation Long-term

Type de données

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)
Description

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

Type de données

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
Description

Persistent atrial fibrillation Documentation

Type de données

boolean

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

Informed Consent

Type de données

boolean

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

Eligibility Procedure Hybrid

Type de données

boolean

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

Exclusion Criteria

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

Pregnancy | Pregnancy, Planned

Type de données

boolean

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

Comorbidity Limiting Life Expectancy

Type de données

boolean

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

Cardiac Surgery procedures

Type de données

boolean

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

Operation on abdominal region | Access Epicardial Excluded

Type de données

boolean

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

Pericarditis

Type de données

boolean

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

Cerebrovascular accident | Transient Ischemic Attack Resolution Excluded

Type de données

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
Description

Communicable Disease | Sepsis

Type de données

boolean

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

Ulcer of esophagus | Esophageal Stenosis | Esophageal Varices

Type de données

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)
Description

Renal dysfunction | Dialysis Absent | Glomerular Filtration Rate

Type de données

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
Description

Medical contraindication Anticoagulants | Medical contraindication Heparin | Medical contraindication Coumadin

Type de données

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
Description

Ventricular arrhythmia Treated

Type de données

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)
Description

Left atrial catheter ablation Atrial Fibrillation

Type de données

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
Description

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

Type de données

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)
Description

Incompetence | Guardian Required | Patient Representative Required

Type de données

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
Retour au début de la page

Similar models

Eligibility Persistent Atrial Fibrillation NCT02344394

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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