ID

37656

Description

Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02294929

Link

https://clinicaltrials.gov/show/NCT02294929

Keywords

Versions (1)
  1. 8/14/19 8/14/19 -
Copyright Holder

See clinicaltrials.gov

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August 14, 2019

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02294929

English

Eligibility Atrial Fibrillation NCT02294929

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with longstanding persistent af, with continuous af of greater than one year, as verified by ecg or telemetry strip at least one year ago, and at inclusion but with no documentation of sinus rhythm in between.
Description

Longstanding persistent atrial fibrillation Duration ECG rhythm strip | Longstanding persistent atrial fibrillation Duration Telemetry | Sinus rhythm Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3873617
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C2022160
UMLS CUI [2,1]
C3873617
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0039451
UMLS CUI [3,1]
C0232201
UMLS CUI [3,2]
C0332197
2. atrial fibrillation should be confirmed on at least 2 consecutive ecg supporting the presence of af for at least one year.
Description

Atrial Fibrillation Disease length | ECG Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C1265611
3. patients with symptoms corresponding to at least ehra score 2.
Description

Symptoms Heart rhythm Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0232187
UMLS CUI [1,3]
C0008902
4. patients, who have not previously undergone an af ablation procedure, should have failed at least a betablocker or class i or iii antiarrhythmic drug.
Description

Catheter ablation for atrial fibrillation Absent | Adrenergic beta-Antagonist failed | Anti-Arrhythmia Agents Class failed

Data type

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0001645
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0003195
UMLS CUI [3,2]
C0456387
UMLS CUI [3,3]
C0231175
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. sinus rhythm cannot be maintained for at least 1 minute after an electrical cardioversion.
Description

Sinus rhythm Maintain Unsuccessful | Status post Electric Countershock

Data type

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0024501
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0013778
2. congestive heart failure with nyha class 3 or more.
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
3. lvef < 35% which is not secondary to af with inadequate rate control, according to the judgement of the investigator.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
4. la diameter ≥ 55 mm by echocardiography.
Description

Left atrium Diameter Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0013516
5. prior af ablation procedure of any kind.
Description

Catheter ablation for atrial fibrillation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
6. af secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as af triggered by other uniform supraventricular tachycardia.
Description

Atrial Fibrillation Secondary to Abnormality Transient | Atrial Fibrillation Secondary to Abnormality Reversible | Electrolyte imbalance | Trauma | Recent surgery | Communicable Disease | Toxic ingestion | Thyroid Disease Uncontrolled | Atrial Fibrillation Triggered by Supraventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0205374
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C1704258
UMLS CUI [2,4]
C0205343
UMLS CUI [3]
C0342579
UMLS CUI [4]
C3714660
UMLS CUI [5]
C2169607
UMLS CUI [6]
C0009450
UMLS CUI [7]
C0749596
UMLS CUI [8,1]
C0040128
UMLS CUI [8,2]
C0205318
UMLS CUI [9,1]
C0004238
UMLS CUI [9,2]
C1444748
UMLS CUI [9,3]
C0039240
7. contraindication to treatment with warfarin or other anticoagulants.
Description

Medical contraindication Warfarin therapy | Medical contraindication Anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4303340
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0003280
8. significant valvular disease or planned cardiac intervention.
Description

Valvular disease | Intervention cardiac Planned

Data type

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C1301732
9. hypertrophic cardiomyopathy.
Description

Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
10. recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
Description

Heart Disease | Angina, Unstable | Myocardial Infarction | Revascularization | Valvular disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0581603
UMLS CUI [5]
C3258293
11. implantable cardioverter-defibrillator (icd), biventricular pacing device, or dual chamber- or single chamber pacemaker patients who are dependent on ventricular pacing
Description

Implantable defibrillator | Biventricular Pacing Device | Dual Chamber Pacemaker | Single Chamber Pacemaker | Patient need for Intraventricular pacing

Data type

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C1322649
UMLS CUI [3]
C2911683
UMLS CUI [4]
C2911682
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0199648
12. patients with intra-atrial thrombus, tumor, pulmonary embolism or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
Description

Atrial thrombus | Neoplasm | Pulmonary Embolism | Abnormality Excludes Transseptal catheter | Abnormality Excludes Vascular access

Data type

boolean

Alias
UMLS CUI [1]
C0340517
UMLS CUI [2]
C0027651
UMLS CUI [3]
C0034065
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1272580
UMLS CUI [5,1]
C1704258
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0750138
13. renal failure requiring dialysis or abnormalities of liver function tests.
Description

Kidney Failure Requirement Dialysis | Liver function tests abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2]
C0151766
14. participant in investigational clinical or device trial.
Description

Study Subject Participation Status | Clinical Trial | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C2346570
15. unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
Description

Informed Consent Unwilling | Informed Consent Unable | Patient unavailable Follow-up | Mental problem Limiting Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C1301818
UMLS CUI [3,2]
C3274571
UMLS CUI [4,1]
C0848067
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C1321605
16. active abuse of alcohol or other substance which may be causative of af and/or might affect compliance.
Description

Substance Use Disorders Causing Atrial Fibrillation | Substance Use Disorders Affecting Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1321605
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Similar models

Eligibility Atrial Fibrillation NCT02294929

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Longstanding persistent atrial fibrillation Duration ECG rhythm strip | Longstanding persistent atrial fibrillation Duration Telemetry | Sinus rhythm Absent
Item
1. patients with longstanding persistent af, with continuous af of greater than one year, as verified by ecg or telemetry strip at least one year ago, and at inclusion but with no documentation of sinus rhythm in between.
boolean
C3873617 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C2022160 (UMLS CUI [1,3])
C3873617 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0039451 (UMLS CUI [2,3])
C0232201 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Atrial Fibrillation Disease length | ECG Quantity
Item
2. atrial fibrillation should be confirmed on at least 2 consecutive ecg supporting the presence of af for at least one year.
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Symptoms Heart rhythm Classification
Item
3. patients with symptoms corresponding to at least ehra score 2.
boolean
C1457887 (UMLS CUI [1,1])
C0232187 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
Catheter ablation for atrial fibrillation Absent | Adrenergic beta-Antagonist failed | Anti-Arrhythmia Agents Class failed
Item
4. patients, who have not previously undergone an af ablation procedure, should have failed at least a betablocker or class i or iii antiarrhythmic drug.
boolean
C2702800 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001645 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0003195 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Sinus rhythm Maintain Unsuccessful | Status post Electric Countershock
Item
1. sinus rhythm cannot be maintained for at least 1 minute after an electrical cardioversion.
boolean
C0232201 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
Congestive heart failure New York Heart Association Classification
Item
2. congestive heart failure with nyha class 3 or more.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
3. lvef < 35% which is not secondary to af with inadequate rate control, according to the judgement of the investigator.
boolean
C0428772 (UMLS CUI [1])
Left atrium Diameter Echocardiography
Item
4. la diameter ≥ 55 mm by echocardiography.
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Catheter ablation for atrial fibrillation Previous
Item
5. prior af ablation procedure of any kind.
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Atrial Fibrillation Secondary to Abnormality Transient | Atrial Fibrillation Secondary to Abnormality Reversible | Electrolyte imbalance | Trauma | Recent surgery | Communicable Disease | Toxic ingestion | Thyroid Disease Uncontrolled | Atrial Fibrillation Triggered by Supraventricular tachycardia
Item
6. af secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as af triggered by other uniform supraventricular tachycardia.
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205374 (UMLS CUI [1,4])
C0004238 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C0205343 (UMLS CUI [2,4])
C0342579 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C2169607 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0749596 (UMLS CUI [7])
C0040128 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0004238 (UMLS CUI [9,1])
C1444748 (UMLS CUI [9,2])
C0039240 (UMLS CUI [9,3])
Medical contraindication Warfarin therapy | Medical contraindication Anticoagulants
Item
7. contraindication to treatment with warfarin or other anticoagulants.
boolean
C1301624 (UMLS CUI [1,1])
C4303340 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0003280 (UMLS CUI [2,2])
Valvular disease | Intervention cardiac Planned
Item
8. significant valvular disease or planned cardiac intervention.
boolean
C3258293 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Hypertrophic Cardiomyopathy
Item
9. hypertrophic cardiomyopathy.
boolean
C0007194 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Myocardial Infarction | Revascularization | Valvular disease
Item
10. recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0581603 (UMLS CUI [4])
C3258293 (UMLS CUI [5])
Implantable defibrillator | Biventricular Pacing Device | Dual Chamber Pacemaker | Single Chamber Pacemaker | Patient need for Intraventricular pacing
Item
11. implantable cardioverter-defibrillator (icd), biventricular pacing device, or dual chamber- or single chamber pacemaker patients who are dependent on ventricular pacing
boolean
C0162589 (UMLS CUI [1])
C1322649 (UMLS CUI [2])
C2911683 (UMLS CUI [3])
C2911682 (UMLS CUI [4])
C0686904 (UMLS CUI [5,1])
C0199648 (UMLS CUI [5,2])
Atrial thrombus | Neoplasm | Pulmonary Embolism | Abnormality Excludes Transseptal catheter | Abnormality Excludes Vascular access
Item
12. patients with intra-atrial thrombus, tumor, pulmonary embolism or another abnormality in whom transseptal catheterization or appropriate vascular access is precluded.
boolean
C0340517 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C1704258 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1272580 (UMLS CUI [4,3])
C1704258 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0750138 (UMLS CUI [5,3])
Kidney Failure Requirement Dialysis | Liver function tests abnormal
Item
13. renal failure requiring dialysis or abnormalities of liver function tests.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0151766 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Investigational Medical Device
Item
14. participant in investigational clinical or device trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Informed Consent Unwilling | Informed Consent Unable | Patient unavailable Follow-up | Mental problem Limiting Compliance
Item
15. unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1301818 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0848067 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
Substance Use Disorders Causing Atrial Fibrillation | Substance Use Disorders Affecting Compliance
Item
16. active abuse of alcohol or other substance which may be causative of af and/or might affect compliance.
boolean
C0038586 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
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