ID

37532

Beskrivning

Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF); ODM derived from: https://clinicaltrials.gov/show/NCT01696136

Länk

https://clinicaltrials.gov/show/NCT01696136

Nyckelord

Versioner (1)
  1. 2019-08-06 2019-08-06 -
Rättsinnehavare

See clinicaltrials.gov

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6 augusti 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01696136

Engelsk

Eligibility Atrial Fibrillation NCT01696136

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 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 with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm
Beskrivning

Atrial Fibrillation Episode Duration | Conversion to sinus rhythm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C1321500
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 Paroxysmal atrial fibrillation Quantity Electrocardiography | Event Paroxysmal atrial fibrillation Quantity Event recording | Event Paroxysmal atrial fibrillation Pacemaker Strip | Event Paroxysmal atrial fibrillation Quantity Rhythm strip monitoring

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0235480
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1623258
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0235480
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1273297
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C0235480
UMLS CUI [3,3]
C0030163
UMLS CUI [3,4]
C1321564
UMLS CUI [4,1]
C0441471
UMLS CUI [4,2]
C0235480
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0204917
af symptoms defined as the manifestation of any of the following:
Beskrivning

Atrial Fibrillation Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1457887
palpitations
Beskrivning

Palpitations

Datatyp

boolean

Alias
UMLS CUI [1]
C0030252
fatigue
Beskrivning

Fatigue

Datatyp

boolean

Alias
UMLS CUI [1]
C0015672
exertional dyspnea
Beskrivning

Dyspnea on exertion

Datatyp

boolean

Alias
UMLS CUI [1]
C0231807
effort intolerance
Beskrivning

Difficulty with Exertion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C0015264
2. age between 18 and 70
Beskrivning

Age

Datatyp

boolean

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

Participation Evaluation procedure

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. structural heart disease of clinical significance including:
Beskrivning

Structural disorder of heart

Datatyp

boolean

Alias
UMLS CUI [1]
C1290384
previous cardiac surgery (excluding cabg)
Beskrivning

Cardiac Surgery Previous | Exception Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0010055
symptoms of congestive heart failure including, but not limited to, nyha class iii or iv chf and/or documented ejection fraction < 40% measured by acceptable cardiac testing
Beskrivning

Symptoms Congestive heart failure | Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction Cardiac Function Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0018802
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0018803
left atrial diameter of > 50mm as measured in the parasternal long axis on transthoracic echocardiogram
Beskrivning

Left atrium Diameter | Transthoracic echocardiography Parasternal long axis view

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0430462
UMLS CUI [2,2]
C1302222
stable/unstable angina or ongoing myocardial ischemia
Beskrivning

Stable angina | Angina, Unstable | Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0151744
myocardial infarction (mi) within three months of enrollment
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
aortic or mitral valve disease > grade ii
Beskrivning

Aortic valve disorder Grade | Disease of mitral valve Grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1260873
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0026265
UMLS CUI [2,2]
C0441800
congenital heart disease (not including asd or pfo without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
Beskrivning

Congenital heart disease | Exception Atrial Septal Defect Without Right to left shunt | Exception Patent Foramen Ovale Without Right to left shunt | Abnormality Increases Risk Ablation

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018817
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0428871
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0016522
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C0428871
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C0205217
UMLS CUI [4,3]
C0035647
UMLS CUI [4,4]
C0547070
prior asd or pfo closure with a device using a percutaneous approach
Beskrivning

Percutaneous closure of atrial septal defect | Percutaneous closure of patent foramen ovale

Datatyp

boolean

Alias
UMLS CUI [1]
C0844084
UMLS CUI [2]
C2051312
hypertrophic cardiomyopathy (lv wall thickness > 1.5 cm)
Beskrivning

Hypertrophic Cardiomyopathy | Wall of left ventricle Thickness

Datatyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2,1]
C0504053
UMLS CUI [2,2]
C1280412
pulmonary hypertension (mean or systolic pa pressure >50mm hg on doppler echo
Beskrivning

Pulmonary Hypertension | Pulmonary artery mean pressure Doppler Echocardiography | Pulmonary artery systolic pressure Doppler Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0020542
UMLS CUI [2,1]
C0428645
UMLS CUI [2,2]
C0013520
UMLS CUI [3,1]
C0428643
UMLS CUI [3,2]
C0013520
2. prior ablation for arrhythmias other than af within the past three months
Beskrivning

Ablation operation for arrhythmia Previous | Exception Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0397403
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004238
3. prior left sided af ablation
Beskrivning

Catheter ablation for atrial fibrillation Left sided

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0443246
4. enrollment in any other ongoing arrhythmia study protocol any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
Beskrivning

Study Subject Participation Status | Cardiac Arrhythmia Interferes with Clinical Trial | Tachycardia, Ventricular | Disease Management Interferes with Clinical Trials

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [3]
C0042514
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0008976
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Similar models

Eligibility Atrial Fibrillation NCT01696136

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation Symptomatic
Item
1. history of symptomatic paroxysmal atrial fibrillation defined as:
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Atrial Fibrillation Episode Duration | Conversion to sinus rhythm
Item
self-terminating af with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1321500 (UMLS CUI [2])
Event Paroxysmal atrial fibrillation Quantity Electrocardiography | Event Paroxysmal atrial fibrillation Quantity Event recording | Event Paroxysmal atrial fibrillation Pacemaker Strip | Event Paroxysmal atrial fibrillation Quantity 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])
C0235480 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1623258 (UMLS CUI [1,4])
C0441471 (UMLS CUI [2,1])
C0235480 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1273297 (UMLS CUI [2,4])
C0441471 (UMLS CUI [3,1])
C0235480 (UMLS CUI [3,2])
C0030163 (UMLS CUI [3,3])
C1321564 (UMLS CUI [3,4])
C0441471 (UMLS CUI [4,1])
C0235480 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0204917 (UMLS CUI [4,4])
Atrial Fibrillation Symptoms
Item
af symptoms defined as the manifestation of any of the following:
boolean
C0004238 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Palpitations
Item
palpitations
boolean
C0030252 (UMLS CUI [1])
Fatigue
Item
fatigue
boolean
C0015672 (UMLS CUI [1])
Dyspnea on exertion
Item
exertional dyspnea
boolean
C0231807 (UMLS CUI [1])
Difficulty with Exertion
Item
effort intolerance
boolean
C0332218 (UMLS CUI [1,1])
C0015264 (UMLS CUI [1,2])
Age
Item
2. age between 18 and 70
boolean
C0001779 (UMLS CUI [1])
Participation Evaluation procedure
Item
3. 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])
Item Group
C0680251 (UMLS CUI)
Structural disorder of heart
Item
1. structural heart disease of clinical significance including:
boolean
C1290384 (UMLS CUI [1])
Cardiac Surgery Previous | Exception Coronary Artery Bypass Surgery
Item
previous cardiac surgery (excluding cabg)
boolean
C0018821 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
Symptoms Congestive heart failure | Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction Cardiac Function Testing
Item
symptoms of congestive heart failure including, but not limited to, nyha class iii or iv chf and/or documented ejection fraction < 40% measured by acceptable cardiac testing
boolean
C1457887 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0018803 (UMLS CUI [3,2])
Left atrium Diameter | Transthoracic echocardiography Parasternal long axis view
Item
left atrial diameter of > 50mm as measured in the parasternal long axis on transthoracic echocardiogram
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0430462 (UMLS CUI [2,1])
C1302222 (UMLS CUI [2,2])
Stable angina | Angina, Unstable | Myocardial Ischemia
Item
stable/unstable angina or ongoing myocardial ischemia
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0151744 (UMLS CUI [3])
Myocardial Infarction
Item
myocardial infarction (mi) within three months of enrollment
boolean
C0027051 (UMLS CUI [1])
Aortic valve disorder Grade | Disease of mitral valve Grade
Item
aortic or mitral valve disease > grade ii
boolean
C1260873 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0026265 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Congenital heart disease | Exception Atrial Septal Defect Without Right to left shunt | Exception Patent Foramen Ovale Without Right to left shunt | Abnormality Increases Risk Ablation
Item
congenital heart disease (not including asd or pfo without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
boolean
C0152021 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018817 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0428871 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0016522 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C0428871 (UMLS CUI [3,4])
C1704258 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0035647 (UMLS CUI [4,3])
C0547070 (UMLS CUI [4,4])
Percutaneous closure of atrial septal defect | Percutaneous closure of patent foramen ovale
Item
prior asd or pfo closure with a device using a percutaneous approach
boolean
C0844084 (UMLS CUI [1])
C2051312 (UMLS CUI [2])
Hypertrophic Cardiomyopathy | Wall of left ventricle Thickness
Item
hypertrophic cardiomyopathy (lv wall thickness > 1.5 cm)
boolean
C0007194 (UMLS CUI [1])
C0504053 (UMLS CUI [2,1])
C1280412 (UMLS CUI [2,2])
Pulmonary Hypertension | Pulmonary artery mean pressure Doppler Echocardiography | Pulmonary artery systolic pressure Doppler Echocardiography
Item
pulmonary hypertension (mean or systolic pa pressure >50mm hg on doppler echo
boolean
C0020542 (UMLS CUI [1])
C0428645 (UMLS CUI [2,1])
C0013520 (UMLS CUI [2,2])
C0428643 (UMLS CUI [3,1])
C0013520 (UMLS CUI [3,2])
Ablation operation for arrhythmia Previous | Exception Atrial Fibrillation
Item
2. prior ablation for arrhythmias other than af within the past three months
boolean
C0397403 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
Catheter ablation for atrial fibrillation Left sided
Item
3. prior left sided af ablation
boolean
C2702800 (UMLS CUI [1,1])
C0443246 (UMLS CUI [1,2])
Study Subject Participation Status | Cardiac Arrhythmia Interferes with Clinical Trial | Tachycardia, Ventricular | Disease Management Interferes with Clinical Trials
Item
4. enrollment in any other ongoing arrhythmia study protocol any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
boolean
C2348568 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0042514 (UMLS CUI [3])
C0376636 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
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