ID

24988

Beskrivning

Ablation of the Pulmonary Veins for Paroxysmal Afib; ODM derived from: https://clinicaltrials.gov/show/NCT00744874

Länk

https://clinicaltrials.gov/show/NCT00744874

Nyckelord

Versioner (1)
  1. 2017-08-23 2017-08-23 -
Uppladdad den

23 augusti 2017

DOI

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Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT00744874

Engelsk

Eligibility Paroxysmal Atrial Fibrillation NCT00744874

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of symptomatic paroxysmal atrial fibrillation defined as:
Beskrivning

Paroxysmal atrial fibrillation Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0231220
self terminating af lasting no more than 7 days
Beskrivning

Atrial Fibrillation Duration Ending Spontaneous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0205359
af events demostrating spontaneous conversion back to sinus rhythm
Beskrivning

Atrial Fibrillation Event | Conversion Spontaneous Sinus rhythm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0441471
UMLS CUI [2,1]
C0439836
UMLS CUI [2,2]
C0205359
UMLS CUI [2,3]
C0232201
documentation of one or more events with paf tracings by ecg, event recordings, pacemaker strips or monitor rhythm strips within the past year
Beskrivning

Event Quantity | Atrial Fibrillation Postoperative Electrocardiography | Cardiac event recording | Electrocardiographic recording from artificial pacemaker | Rhythm strip monitoring

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0032790
UMLS CUI [2,3]
C1623258
UMLS CUI [3]
C1273297
UMLS CUI [4]
C0199561
UMLS CUI [5]
C0204917
af symptoms defined as the manisfestation of any of the following: palpitations, fatigue, exertional dyspnea, effort intolerance
Beskrivning

Atrial Fibrillation Symptoms | Palpitations | Fatigue | Dyspnea on exertion | Effort intolerant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0030252
UMLS CUI [3]
C0015672
UMLS CUI [4]
C0231807
UMLS CUI [5,1]
C0015264
UMLS CUI [5,2]
C0231200
age between 18 and 70
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Beskrivning

Participation Evaluation | Participation Follow-up Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C1261322
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1522577
UMLS CUI [2,3]
C1261322
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
structural heart disease of clinical significance
Beskrivning

Structural disorder of heart

Datatyp

boolean

Alias
UMLS CUI [1]
C1290384
prior ablation for arrhythmias other than af within the past three months
Beskrivning

Ablation operation for arrhythmia | Exception Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0397403
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004238
prior left sided af ablation
Beskrivning

Ablation Atrial Fibrillation Left sided

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0443246
enrollment in any other ongoing arrhythmia study protocol
Beskrivning

Study Subject Participation Status | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0003811
any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
Beskrivning

Ventricular Tachycardia Treated Interferes with Clinical Trial | Disease Management Interferes with Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
active infection or sepsis
Beskrivning

Communicable Disease | Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0243026
any history of cerebral vascular disease including stroke or tias
Beskrivning

Cerebrovascular Disorders | Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
pregnancy or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
untreatable allergy to contrast media
Beskrivning

Contrast media allergy | Therapeutic procedure Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1272705
any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
Beskrivning

Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Diseases | Atrial Fibrillation Secondary to Causes Reversible | Atrial Fibrillation Secondary to Causes

Datatyp

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
history of blood clotting (bleeding or thrombotic) abnormalities
Beskrivning

Abnormality of coagulation | Bleeding tendency | Abnormal thrombosis

Datatyp

boolean

Alias
UMLS CUI [1]
C1846821
UMLS CUI [2]
C1458140
UMLS CUI [3]
C4025731
known sensitivities to heparin or warfarin
Beskrivning

Heparin allergy | Warfarin allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571776
UMLS CUI [2]
C0571785
severe copd (identified by an fev1 < 1)
Beskrivning

Severe chronic obstructive pulmonary disease Pulmonary Function Test/Forced Expiratory Volume 1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730607
UMLS CUI [1,2]
C0849974
severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Beskrivning

Comorbidity Severe Study Subject Participation Status Unfavorable | General health poor Study Subject Participation Status Unfavorable | Disease Process | Mental state | Substance Use Disorders | Life expectancy shortened

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C3640815
UMLS CUI [2,1]
C1277248
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1522240
UMLS CUI [4]
C0278060
UMLS CUI [5]
C0038586
UMLS CUI [6]
C1504437
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Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT00744874

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation Symptomatic
Item
history of symptomatic paroxysmal atrial fibrillation defined as:
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Atrial Fibrillation Duration Ending Spontaneous
Item
self terminating af lasting no more than 7 days
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0205359 (UMLS CUI [1,4])
Atrial Fibrillation Event | Conversion Spontaneous Sinus rhythm
Item
af events demostrating spontaneous conversion back to sinus rhythm
boolean
C0004238 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0439836 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0232201 (UMLS CUI [2,3])
Event Quantity | Atrial Fibrillation Postoperative Electrocardiography | Cardiac event recording | Electrocardiographic recording from artificial pacemaker | Rhythm strip monitoring
Item
documentation of one or more events with paf tracings by ecg, event recordings, pacemaker strips or monitor rhythm strips within the past year
boolean
C0441471 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0032790 (UMLS CUI [2,2])
C1623258 (UMLS CUI [2,3])
C1273297 (UMLS CUI [3])
C0199561 (UMLS CUI [4])
C0204917 (UMLS CUI [5])
Atrial Fibrillation Symptoms | Palpitations | Fatigue | Dyspnea on exertion | Effort intolerant
Item
af symptoms defined as the manisfestation of any of the following: palpitations, fatigue, exertional dyspnea, effort intolerance
boolean
C0004238 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0030252 (UMLS CUI [2])
C0015672 (UMLS CUI [3])
C0231807 (UMLS CUI [4])
C0015264 (UMLS CUI [5,1])
C0231200 (UMLS CUI [5,2])
Age
Item
age between 18 and 70
boolean
C0001779 (UMLS CUI [1])
Participation Evaluation | Participation Follow-up Evaluation
Item
willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
boolean
C0679823 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Structural disorder of heart
Item
structural heart disease of clinical significance
boolean
C1290384 (UMLS CUI [1])
Ablation operation for arrhythmia | Exception Atrial Fibrillation
Item
prior ablation for arrhythmias other than af within the past three months
boolean
C0397403 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
Ablation Atrial Fibrillation Left sided
Item
prior left sided af ablation
boolean
C0547070 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,3])
Study Subject Participation Status | Cardiac Arrhythmia
Item
enrollment in any other ongoing arrhythmia study protocol
boolean
C2348568 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
Ventricular Tachycardia Treated Interferes with Clinical Trial | Disease Management Interferes with Clinical Trial
Item
any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
boolean
C0042514 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0376636 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Communicable Disease | Sepsis
Item
active infection or sepsis
boolean
C0009450 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Cerebrovascular Disorders | Cerebrovascular accident | Transient Ischemic Attack
Item
any history of cerebral vascular disease including stroke or tias
boolean
C0007820 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contrast media allergy | Therapeutic procedure Unsuccessful
Item
untreatable allergy to contrast media
boolean
C0570562 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Diseases | Atrial Fibrillation Secondary to Causes Reversible | Atrial Fibrillation Secondary to Causes
Item
any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
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])
Abnormality of coagulation | Bleeding tendency | Abnormal thrombosis
Item
history of blood clotting (bleeding or thrombotic) abnormalities
boolean
C1846821 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C4025731 (UMLS CUI [3])
Heparin allergy | Warfarin allergy
Item
known sensitivities to heparin or warfarin
boolean
C0571776 (UMLS CUI [1])
C0571785 (UMLS CUI [2])
Severe chronic obstructive pulmonary disease Pulmonary Function Test/Forced Expiratory Volume 1
Item
severe copd (identified by an fev1 < 1)
boolean
C0730607 (UMLS CUI [1,1])
C0849974 (UMLS CUI [1,2])
Comorbidity Severe Study Subject Participation Status Unfavorable | General health poor Study Subject Participation Status Unfavorable | Disease Process | Mental state | Substance Use Disorders | Life expectancy shortened
Item
severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C1277248 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C1522240 (UMLS CUI [3,2])
C0278060 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C1504437 (UMLS CUI [6])
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