ID

37546

Descrição

A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01729871

Link

https://clinicaltrials.gov/show/NCT01729871

Palavras-chave

Versões (1)
  1. 06/08/2019 06/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01729871

Inglês

Eligibility Atrial Fibrillation NCT01729871

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation (nvaf);
Descrição

Catheter ablation for atrial fibrillation Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205539
have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (>=1 year) nvaf;
Descrição

Paroxysmal atrial fibrillation Disease length | Persistent atrial fibrillation Disease length | Persistent atrial fibrillation Requirement Pharmacological cardioversion | Persistent atrial fibrillation Requirement Electric Countershock | Longstanding persistent atrial fibrillation Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C2585653
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1963873
UMLS CUI [4,1]
C2585653
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0013778
UMLS CUI [5,1]
C3873617
UMLS CUI [5,2]
C0872146
be suitable for anticoagulant therapy and catheter ablation as per the judgment of the investigator;
Descrição

Patient Suitable Anticoagulant therapy | Patient Suitable Catheter ablation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0150457
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0162563
women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active;
Descrição

Postmenopausal state | Gender Sexually active Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
women of childbearing potential must have a negative serum pregnancy test at screening;
Descrição

Childbearing Potential Serum pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
be willing and able to adhere to the prohibitions and restrictions specified in the study protocol;
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
have a life expectancy of at least 6 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of a prior stroke, transient ischemic attack (tia) or non-convulsive status epilepticus within 6 months of the screening visit;
Descrição

Cerebrovascular accident | Transient Ischemic Attack | Non-Convulsive Status Epilepticus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0751523
has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure;
Descrição

Hemorrhage Major | Thromboembolism

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0040038
has had major surgery (requiring general anesthesia), within 6 months before screening or planned surgery during the time the subject is expected to participate in the study;
Descrição

Major surgery Requirement General Anesthesia | Operative Surgical Procedure Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0002915
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301732
has nvaf due to electrolyte imbalance, hyperthyroidism, or other reversible or noncardiac cause of nvaf;
Descrição

Atrial Fibrillation Due to Electrolyte imbalance | Atrial Fibrillation Due to Hyperthyroidism | Atrial Fibrillation Due to Cause Reversible | Exception Cause cardiac

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0342579
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0020550
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0205343
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015127
UMLS CUI [4,3]
C0018787
has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Descrição

Condition Study Subject Participation Status Unfavorable | Condition compromises Health | Condition Preventing Protocol Assessment | Condition Limiting Protocol Assessment | Condition Interferes with Protocol Assessment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0018684
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2348563
UMLS CUI [3,4]
C1516048
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C2348563
UMLS CUI [4,4]
C1516048
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348563
UMLS CUI [5,4]
C1516048
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Similar models

Eligibility Atrial Fibrillation NCT01729871

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Catheter ablation for atrial fibrillation Scheduled
Item
be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation (nvaf);
boolean
C2702800 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Paroxysmal atrial fibrillation Disease length | Persistent atrial fibrillation Disease length | Persistent atrial fibrillation Requirement Pharmacological cardioversion | Persistent atrial fibrillation Requirement Electric Countershock | Longstanding persistent atrial fibrillation Disease length
Item
have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (>=1 year) nvaf;
boolean
C0235480 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C2585653 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1963873 (UMLS CUI [3,3])
C2585653 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013778 (UMLS CUI [4,3])
C3873617 (UMLS CUI [5,1])
C0872146 (UMLS CUI [5,2])
Patient Suitable Anticoagulant therapy | Patient Suitable Catheter ablation
Item
be suitable for anticoagulant therapy and catheter ablation as per the judgment of the investigator;
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0150457 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0162563 (UMLS CUI [2,3])
Postmenopausal state | Gender Sexually active Contraceptive methods
Item
women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active;
boolean
C0232970 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Childbearing Potential Serum pregnancy test negative
Item
women of childbearing potential must have a negative serum pregnancy test at screening;
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Protocol Compliance
Item
be willing and able to adhere to the prohibitions and restrictions specified in the study protocol;
boolean
C0525058 (UMLS CUI [1])
Life Expectancy
Item
have a life expectancy of at least 6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Transient Ischemic Attack | Non-Convulsive Status Epilepticus
Item
has a history of a prior stroke, transient ischemic attack (tia) or non-convulsive status epilepticus within 6 months of the screening visit;
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0751523 (UMLS CUI [3])
Hemorrhage Major | Thromboembolism
Item
has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure;
boolean
C0019080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0040038 (UMLS CUI [2])
Major surgery Requirement General Anesthesia | Operative Surgical Procedure Planned
Item
has had major surgery (requiring general anesthesia), within 6 months before screening or planned surgery during the time the subject is expected to participate in the study;
boolean
C0679637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Atrial Fibrillation Due to Electrolyte imbalance | Atrial Fibrillation Due to Hyperthyroidism | Atrial Fibrillation Due to Cause Reversible | Exception Cause cardiac
Item
has nvaf due to electrolyte imbalance, hyperthyroidism, or other reversible or noncardiac cause of nvaf;
boolean
C0004238 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0342579 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0020550 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0205343 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0015127 (UMLS CUI [4,2])
C0018787 (UMLS CUI [4,3])
Condition Study Subject Participation Status Unfavorable | Condition compromises Health | Condition Preventing Protocol Assessment | Condition Limiting Protocol Assessment | Condition Interferes with Protocol Assessment
Item
has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0018684 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C1516048 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
C1516048 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348563 (UMLS CUI [5,3])
C1516048 (UMLS CUI [5,4])
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