ID

34834

Description

PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02463851

Link

https://clinicaltrials.gov/show/NCT02463851

Keywords

Versions (1)
  1. 1/30/19 1/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 30, 2019

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02463851

English

Eligibility Atrial Fibrillation NCT02463851

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. history of symptomatic paroxysmal atrial fibrillation defined as:
Description

Paroxysmal atrial fibrillation Symptomatic

Data type

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
Description

Episodes Atrial Fibrillation Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0449238
documentation of one or more events with paf tracings by ecg, event recordings, pacemaker strips or monitor rhythm strips within the past year
Description

Paroxysmal Atrial Fibrillation by ECG Finding | Cardiac event recording | Rhythm strip monitoring

Data type

boolean

Alias
UMLS CUI [1]
C4050122
UMLS CUI [2]
C1273297
UMLS CUI [3]
C0204917
af symptoms defined as the manifestation of any of the following:
Description

ATRIAL FIBRILLATION SYMPTOMATIC

Data type

boolean

Alias
UMLS CUI [1]
C0741283
palpitations
Description

Palpitations

Data type

boolean

Alias
UMLS CUI [1]
C0030252
fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
exertional dyspnea
Description

Dyspnea on exertion

Data type

boolean

Alias
UMLS CUI [1]
C0231807
effort intolerance
Description

Effort Problem

Data type

boolean

Alias
UMLS CUI [1,1]
C0015264
UMLS CUI [1,2]
C0033213
2. age between 18 and 70 willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Description

Age | Participation Baseline Evaluation | Participation Follow-up Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1442488
UMLS CUI [2,3]
C1261322
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C1522577
UMLS CUI [3,3]
C1261322
Exclusion Criteria
Description

Exclusion Criteria

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

Structural disorder of heart

Data type

boolean

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

Cardiac Surgery procedures | Exception Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0018821
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
Description

Symptomatic congestive heart failure | Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0742758
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0232174
left atrial diameter of > 45mm as measured in the parasternal long axis on transthoracic echocardiogram
Description

Left atrium Diameter | Parasternal long axis view Transthoracic echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C1302222
UMLS CUI [2,2]
C0430462
la volume>40 ml/m2
Description

Left atrium Volume

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0449468
stable/unstable angina or ongoing myocardial ischemia
Description

Stable angina | Angina, Unstable | Myocardial Ischemia

Data type

boolean

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

Myocardial Infarction

Data type

boolean

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

Aortic valve disorder CTCAE Grades | Diseases of mitral valve CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C1260873
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0026265
UMLS CUI [2,2]
C1516728
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
Description

Congenital heart disease | Exception Atrial Septal Defects Without Right to left cardiac shunt | Exception Patent Foramen Ovale Without Right to left cardiac shunt

Data type

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]
C2711956
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0016522
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C2711956
prior asd or pfo closure with a device using a percutaneous approach
Description

Atrial septal defect closure Percutaneous approach | Closure of patent foramen ovale Percutaneous approach

Data type

boolean

Alias
UMLS CUI [1,1]
C0189965
UMLS CUI [1,2]
C0522523
UMLS CUI [2,1]
C0189967
UMLS CUI [2,2]
C0522523
hypertrophic cardiomyopathy (lv wall thickness > 1.5 cm)
Description

Hypertrophic Cardiomyopathy | Left ventricular segmental wall thickness

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0455826
pulmonary hypertension (mean or systolic pa pressure >50mm hg on doppler echo
Description

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

Data type

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
Description

Ablation operation for arrhythmia | Exception Atrial Fibrillation

Data type

boolean

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

Catheter ablation for atrial fibrillation Left sided

Data type

boolean

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

Study Subject Participation Status | Clinical Trial Cardiac Arrhythmia | Treatment Ventricular Tachyarrhythmia | Interference Clinical Trial Current

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0003811
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0042514
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C0008976
UMLS CUI [4,3]
C0521116
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Similar models

Eligibility Atrial Fibrillation NCT02463851

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Episodes Atrial Fibrillation Duration
Item
self-terminating af with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm
boolean
C0332189 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Paroxysmal Atrial Fibrillation by ECG Finding | Cardiac event recording | 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
C4050122 (UMLS CUI [1])
C1273297 (UMLS CUI [2])
C0204917 (UMLS CUI [3])
ATRIAL FIBRILLATION SYMPTOMATIC
Item
af symptoms defined as the manifestation of any of the following:
boolean
C0741283 (UMLS CUI [1])
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])
Effort Problem
Item
effort intolerance
boolean
C0015264 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
Age | Participation Baseline Evaluation | Participation Follow-up Evaluation
Item
2. age between 18 and 70 willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
boolean
C0001779 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0679823 (UMLS CUI [3,1])
C1522577 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
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 procedures | Exception Coronary Artery Bypass Surgery
Item
previous cardiac surgery (excluding cabg)
boolean
C0018821 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
Symptomatic congestive heart failure | Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction
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
C0742758 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3])
Left atrium Diameter | Parasternal long axis view Transthoracic echocardiography
Item
left atrial diameter of > 45mm as measured in the parasternal long axis on transthoracic echocardiogram
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1302222 (UMLS CUI [2,1])
C0430462 (UMLS CUI [2,2])
Left atrium Volume
Item
la volume>40 ml/m2
boolean
C0225860 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
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 CTCAE Grades | Diseases of mitral valve CTCAE Grades
Item
aortic or mitral valve disease > grade ii
boolean
C1260873 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0026265 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Congenital heart disease | Exception Atrial Septal Defects Without Right to left cardiac shunt | Exception Patent Foramen Ovale Without Right to left cardiac shunt
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])
C2711956 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0016522 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C2711956 (UMLS CUI [3,4])
Atrial septal defect closure Percutaneous approach | Closure of patent foramen ovale Percutaneous approach
Item
prior asd or pfo closure with a device using a percutaneous approach
boolean
C0189965 (UMLS CUI [1,1])
C0522523 (UMLS CUI [1,2])
C0189967 (UMLS CUI [2,1])
C0522523 (UMLS CUI [2,2])
Hypertrophic Cardiomyopathy | Left ventricular segmental wall thickness
Item
hypertrophic cardiomyopathy (lv wall thickness > 1.5 cm)
boolean
C0007194 (UMLS CUI [1])
C0455826 (UMLS CUI [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 | Exception Atrial Fibrillation
Item
2. 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])
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 | Clinical Trial Cardiac Arrhythmia | Treatment Ventricular Tachyarrhythmia | Interference Clinical Trial Current
Item
4. enrollment in any other ongoing arrhythmia study protocol any ventricular tachy-arrhythmias currently being treated where the arrhythmia or the management may interfere with this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0042514 (UMLS CUI [3,2])
C0521102 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
C0521116 (UMLS CUI [4,3])
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