ID

37539

Description

CARTO® 3 System and Real Time Intracardiac Ultrasound; ODM derived from: https://clinicaltrials.gov/show/NCT01716663

Link

https://clinicaltrials.gov/show/NCT01716663

Keywords

Versions (1)
  1. 8/6/19 8/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01716663

English

Eligibility Atrial Fibrillation NCT01716663

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
drug refractory, recurrent symptomatic paroxysmal af
Description

Paroxysmal atrial fibrillation Symptomatic Recurrent | Paroxysmal atrial fibrillation Unresponsive to Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C2945760
UMLS CUI [2,1]
C0235480
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0013227
age 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients able and willing to provide written informed consent to participate in the study and comply with study requirements
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Description

Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Disease | Atrial Fibrillation Secondary to Cause Reversible | Atrial Fibrillation Secondary to Cause | Exception Cause cardiac

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0342579
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0040128
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0205343
UMLS CUI [4,1]
C0004238
UMLS CUI [4,2]
C0175668
UMLS CUI [4,3]
C0015127
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0015127
UMLS CUI [5,3]
C0018787
previous ablation for atrial fibrillation
Description

Catheter ablation for atrial fibrillation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
af episodes that last longer than 30 days
Description

Atrial Fibrillation Episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
uncontrolled heart failure, or nyha class iii or iv heart failure
Description

Heart failure Uncontrolled | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
documented intra-atrial thrombus or other abnormality on pre-ablation imaging
Description

Atrial thrombus Imaging | Abnormality Imaging | Status pre- Ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C0340517
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0011923
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0547070
contraindication to anticoagulation
Description

Medical contraindication Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
Description

Cerebrovascular accident | Cardiac Surgery | Angina, Unstable | Myocardial Infarction | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0018821
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5]
C1532338
awaiting cardiac transplantation
Description

Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
heart disease for which corrective surgery is anticipated within 6 months
Description

Heart Disease | Correction Surgical Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C3840775
enrollment in other investigational drug or device study
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
subjects unwilling to comply with protocol or follow-up requirements
Description

Protocol Compliance Unwilling | Follow-up Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0558080
patients who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Atrial Fibrillation NCT01716663

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation Symptomatic Recurrent | Paroxysmal atrial fibrillation Unresponsive to Pharmaceutical Preparations
Item
drug refractory, recurrent symptomatic paroxysmal af
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0235480 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
patients able and willing to provide written informed consent to participate in the study and comply with study requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Disease | Atrial Fibrillation Secondary to Cause Reversible | Atrial Fibrillation Secondary to Cause | Exception Cause cardiac
Item
atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0342579 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0040128 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0205343 (UMLS CUI [3,4])
C0004238 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0015127 (UMLS CUI [5,2])
C0018787 (UMLS CUI [5,3])
Catheter ablation for atrial fibrillation Previous
Item
previous ablation for atrial fibrillation
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Atrial Fibrillation Episode Duration
Item
af episodes that last longer than 30 days
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Heart failure Uncontrolled | Heart failure New York Heart Association Classification
Item
uncontrolled heart failure, or nyha class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Atrial thrombus Imaging | Abnormality Imaging | Status pre- Ablation
Item
documented intra-atrial thrombus or other abnormality on pre-ablation imaging
boolean
C0340517 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0547070 (UMLS CUI [3,2])
Medical contraindication Anticoagulation Therapy
Item
contraindication to anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Cerebrovascular accident | Cardiac Surgery | Angina, Unstable | Myocardial Infarction | Percutaneous Coronary Intervention
Item
stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
boolean
C0038454 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C1532338 (UMLS CUI [5])
Heart Transplantation Expected
Item
awaiting cardiac transplantation
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Heart Disease | Correction Surgical Anticipated
Item
heart disease for which corrective surgery is anticipated within 6 months
boolean
C0018799 (UMLS CUI [1])
C1947976 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C3840775 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
enrollment in other investigational drug or device study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Protocol Compliance Unwilling | Follow-up Unwilling
Item
subjects unwilling to comply with protocol or follow-up requirements
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy
Item
patients who are pregnant
boolean
C0032961 (UMLS CUI [1])
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