ID

36829

Description

Atrial Fibrillation Ablation Compared to Rate Control Strategy in Patients With Impaired Left Ventricular Function; ODM derived from: https://clinicaltrials.gov/show/NCT02509754

Link

https://clinicaltrials.gov/show/NCT02509754

Keywords

  1. 6/13/19 6/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 13, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Persistent Atrial Fibrillation NCT02509754

Eligibility Persistent Atrial Fibrillation NCT02509754

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recent (no longer than 6 months) diagnosis of congestive heart failure, defined as left ventricular ejection fraction lower or equal than 35% along with the presence of symptoms of heart failure, with a nyha class ii, iii or ambulatory iv;
Description

Congestive heart failure Duration | Left ventricular ejection fraction | Symptoms Heart failure New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0428772
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0018801
UMLS CUI [3,3]
C1275491
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0439841
UMLS CUI [4,3]
C1275491
optimal medical therapy from at least 3 months (including a beta-blocker, an angiotensin-converting-enzyme (ace) inhibitor or angiotensin-receptor blocker (arb) and, in nyha iii and iv patients, spironolactone);
Description

Therapy Optimal | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | New York Heart Association Classification | Spironolactone

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C1275491
UMLS CUI [6]
C0037982
persistent atrial fibrillation (at least 3 months or, alternatively, a minimum of two previous episodes lasting longer than 7 days);
Description

Persistent atrial fibrillation | Episode Duration Quantity

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C1265611
refractory to at least one, or intolerant to, antiarrhythmic drug/s;
Description

Anti-Arrhythmia Agents Quantity Refractory | Intolerance to Anti-Arrhythmia Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003195
must be able to provide written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
reversible causes of atrial fibrillation or congestive heart failure;
Description

Cause Reversible Atrial Fibrillation | Cause Reversible Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0205343
UMLS CUI [2,3]
C0018802
permanent or long-standing persistent atrial fibrillation (lasting more than 1 year);
Description

Permanent atrial fibrillation | Persistent atrial fibrillation Long-term

Data type

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0443252
previous surgical or transcatheter af ablation;
Description

Catheter ablation for atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2702800
previously implanted crt with or without concomitant av node ablation;
Description

CRT Device Implanted | Ablation AV Node | Ablation AV Node Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2936377
UMLS CUI [1,2]
C0021102
UMLS CUI [2]
C3275044
UMLS CUI [3,1]
C3275044
UMLS CUI [3,2]
C0332197
qrs duration above 150 msec or above 120 msec in the presence of complete left bundle branch block (class iia indication for crt implantation);
Description

QRS duration | LBBB complete | Indication Class Implantation CRT Device

Data type

boolean

Alias
UMLS CUI [1]
C0429025
UMLS CUI [2]
C0264915
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0456387
UMLS CUI [3,3]
C0021107
UMLS CUI [3,4]
C2936377
life expectancy of one year or less;
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
high likelihood of undergoing cardiac transplantation within the next year;
Description

Probability High Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0033204
UMLS CUI [1,2]
C0205250
UMLS CUI [1,3]
C0018823
contraindication to anticoagulant therapy;
Description

Medical contraindication Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0150457
documented intraatrial thrombus, tumor, or other abnormality that precludes catheter introduction and manipulation;
Description

Atrial thrombosis | ATRIAL TUMOR | Abnormality Atrial | Catheterization Excluded | Manipulation of catheter Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0340517
UMLS CUI [2]
C0741300
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0018792
UMLS CUI [4,1]
C0007430
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0522773
UMLS CUI [5,2]
C0332196
inability to perform a 6-minute walking test;
Description

6-Minute Walk Test Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C1299582
absence of optimal medical therapy as previously described;
Description

Therapy Optimal Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0332197
cardiac surgery, myocardial infarction or percutaneous coronary intervention within the previous 3 months.
Description

Cardiac Surgery procedures | Myocardial Infarction | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1532338

Similar models

Eligibility Persistent Atrial Fibrillation NCT02509754

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Congestive heart failure Duration | Left ventricular ejection fraction | Symptoms Heart failure New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification
Item
recent (no longer than 6 months) diagnosis of congestive heart failure, defined as left ventricular ejection fraction lower or equal than 35% along with the presence of symptoms of heart failure, with a nyha class ii, iii or ambulatory iv;
boolean
C0018802 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C1275491 (UMLS CUI [3,3])
C0018801 (UMLS CUI [4,1])
C0439841 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
Therapy Optimal | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | New York Heart Association Classification | Spironolactone
Item
optimal medical therapy from at least 3 months (including a beta-blocker, an angiotensin-converting-enzyme (ace) inhibitor or angiotensin-receptor blocker (arb) and, in nyha iii and iv patients, spironolactone);
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0001645 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
C0037982 (UMLS CUI [6])
Persistent atrial fibrillation | Episode Duration Quantity
Item
persistent atrial fibrillation (at least 3 months or, alternatively, a minimum of two previous episodes lasting longer than 7 days);
boolean
C2585653 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Anti-Arrhythmia Agents Quantity Refractory | Intolerance to Anti-Arrhythmia Agents
Item
refractory to at least one, or intolerant to, antiarrhythmic drug/s;
boolean
C0003195 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0003195 (UMLS CUI [2,2])
Informed Consent
Item
must be able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cause Reversible Atrial Fibrillation | Cause Reversible Congestive heart failure
Item
reversible causes of atrial fibrillation or congestive heart failure;
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0205343 (UMLS CUI [2,2])
C0018802 (UMLS CUI [2,3])
Permanent atrial fibrillation | Persistent atrial fibrillation Long-term
Item
permanent or long-standing persistent atrial fibrillation (lasting more than 1 year);
boolean
C2586056 (UMLS CUI [1])
C2585653 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
Catheter ablation for atrial fibrillation
Item
previous surgical or transcatheter af ablation;
boolean
C2702800 (UMLS CUI [1])
CRT Device Implanted | Ablation AV Node | Ablation AV Node Absent
Item
previously implanted crt with or without concomitant av node ablation;
boolean
C2936377 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C3275044 (UMLS CUI [2])
C3275044 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
QRS duration | LBBB complete | Indication Class Implantation CRT Device
Item
qrs duration above 150 msec or above 120 msec in the presence of complete left bundle branch block (class iia indication for crt implantation);
boolean
C0429025 (UMLS CUI [1])
C0264915 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C0021107 (UMLS CUI [3,3])
C2936377 (UMLS CUI [3,4])
Life Expectancy
Item
life expectancy of one year or less;
boolean
C0023671 (UMLS CUI [1])
Probability High Heart Transplantation
Item
high likelihood of undergoing cardiac transplantation within the next year;
boolean
C0033204 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0018823 (UMLS CUI [1,3])
Medical contraindication Anticoagulant therapy
Item
contraindication to anticoagulant therapy;
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
Atrial thrombosis | ATRIAL TUMOR | Abnormality Atrial | Catheterization Excluded | Manipulation of catheter Excluded
Item
documented intraatrial thrombus, tumor, or other abnormality that precludes catheter introduction and manipulation;
boolean
C0340517 (UMLS CUI [1])
C0741300 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0018792 (UMLS CUI [3,2])
C0007430 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0522773 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
6-Minute Walk Test Unable
Item
inability to perform a 6-minute walking test;
boolean
C0430515 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Therapy Optimal Absent
Item
absence of optimal medical therapy as previously described;
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Cardiac Surgery procedures | Myocardial Infarction | Percutaneous Coronary Intervention
Item
cardiac surgery, myocardial infarction or percutaneous coronary intervention within the previous 3 months.
boolean
C0018821 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1532338 (UMLS CUI [3])

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