ID

28482

Description

Continued Access to PREVAIL (CAP2); ODM derived from: https://clinicaltrials.gov/show/NCT01760291

Lien

https://clinicaltrials.gov/show/NCT01760291

Mots-clés

Versions (1)
  1. 17/01/2018 17/01/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

17 janvier 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01760291

Anglais

Eligibility Atrial Fibrillation NCT01760291

1 Formulaires  
Criteria
Description

Criteria

1. the subject is 18 years of age or older
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. the subject has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
Description

paroxysmal, persistent, or permanent non- valvular atrial fibrillation | non- valvular atrial fibrilliation

Type de données

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
UMLS CUI [4,1]
C0004238
UMLS CUI [4,2]
C0018826
UMLS CUI [4,3]
C0332197
3. the subject is eligible for long-term warfarin therapy
Description

warfarin therapy eglibility

Type de données

boolean

Alias
UMLS CUI [1]
C0043031
4. the subject has a calculated chads2 score of 2 or greater;
Description

chads2 score

Type de données

boolean

Alias
UMLS CUI [1]
C2585876
subjects requiring warfarin therapy
Description

subjects with a chads2 score of 1 may be included if any of the following apply (according to the acc/aha/esc 2006 guidelines for the management of subjects with atrial fibrillation)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0686904
the subject is a female age 75 or older
Description

subjects with a chads2 score of 1 may be included if any of the following apply (according to the acc/aha/esc 2006 guidelines for the management of subjects with atrial fibrillation)

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
the subject has a baseline left ventricular ejection fraction (lvef) > 30% and < 35%
Description

subjects with a chads2 score of 1 may be included if any of the following apply (according to the acc/aha/esc 2006 guidelines for the management of subjects with atrial fibrillation)

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
the subject is age 65-74 and has diabetes or coronary artery disease
Description

subjects with a chads2 score of 1 may be included if any of the following apply (according to the acc/aha/esc 2006 guidelines for the management of subjects with atrial fibrillation)

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0011849
the subject is age 65 or greater and has documented congestive heart failure
Description

subjects with a chads2 score of 1 may be included if any of the following apply (according to the acc/aha/esc 2006 guidelines for the management of subjects with atrial fibrillation)

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018802
5. the subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
Description

consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
6. the subject is able and willing to return for required follow-up visits and examinations
Description

follow up

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the subject requires long-term warfarin therapy (i.e., even if the device is implanted, the subjects would not be eligible to discontinue warfarin due to other medical conditions requiring chronic warfarin therapy). additionally, a subject with any of the following is excluded:
Description

warfarin

Type de données

boolean

Alias
UMLS CUI [1]
C0043031
thrombosis occurring at a young age (<40 years old)
Description

thrombosis | age

Type de données

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0001779
idiopathic or recurrent venous thromboembolism
Description

idiopathic venous thromboembolism | recurrent venous thromboembolism

Type de données

boolean

Alias
UMLS CUI [1,1]
C1861172
UMLS CUI [1,2]
C0332240
UMLS CUI [2,1]
C1861172
UMLS CUI [2,2]
C0277556
thrombosis at an unusual site (i.e., cerebral veins, hepatic veins,renal veins, inferior vena cava, mesenteric veins)
Description

thrombosis at unusual site

Type de données

boolean

Alias
UMLS CUI [1,1]
C4086711
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C2700116
family history of venous thromboembolism or of inherited prothrombotic disorder
Description

inherited prothrombotic disorder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0314657
UMLS CUI [1,2]
C0040053
recurrence or extension of thrombosis while adequately anticoagulated
Description

therapy resistant thrombosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C0332325
2. the subject is contraindicated for warfarin therapy or cannot tolerate long-term warfarin therapy
Description

warfarin contraindication

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
3. the subject is contraindicated or allergic to aspirin
Description

aspirin contraindication | aspirin allergy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0522473
UMLS CUI [2]
C0004058
4. the subject is indicated for antiplatelet therapy other than aspirin (for example, a subject indicated for clopidogrel, prasugrel, ticlopidine or ticagrelor due to des is excluded from enrollment during the dosing regimen). a subject completing a course of antiplatelet therapy may be enrolled after a 7 day washout period
Description

antiplatelet therapy

Type de données

boolean

Alias
UMLS CUI [1]
C1096021
5. the subject had any interventional or surgical procedure within 30 days prior to enrollment or is planning to have an interventional or surgical procedure in the time between the watchman device implant and 45-day tee (e.g., cardioversion, ablation, cataract surgery, dental surgery)
Description

surgical procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0543467
6. the subject had a prior stroke or tia within the 90 days prior to enrollment
Description

stroke | tia

Type de données

boolean

Alias
UMLS CUI [1]
C3844446
7. the subject has had an mi within 90 days prior to enrollment
Description

myocardial infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
8. the subject has a history of atrial septal repair or has an asd/pfo device
Description

atrial septal repair

Type de données

boolean

Alias
UMLS CUI [1]
C0189965
9. the subject has an implanted mechanical valve prosthesis
Description

mechanical valve implant

Type de données

boolean

Alias
UMLS CUI [1]
C4062429
10. the subject suffers from new york heart association class iv congestive heart failure at the time of enrollment
Description

ID.27

Type de données

boolean

11. the subject has symptomatic carotid disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual tia evidenced by amaurosis fugax, ipsilateral hemispheric tias or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% stenosis
Description

stenosis

Type de données

boolean

Alias
UMLS CUI [1]
C0007282
12. the subject's af is defined by a single occurrence of af
Description

atrial fibrillation single event

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1948045
13. the subject had a transient case of af (i.e., secondary to cabg, interventional procedure, etc.)
Description

transient atrial fibrilliation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205374
14. the subject's left atrial appendage is obliterated
Description

left atrial appendage obliterated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0598782
UMLS CUI [1,3]
C1293136
15. the subject has undergone heart transplantation
Description

heart transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0018823
16. the subject is currently treated with antibiotics for an active infection
Description

antibiotic treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0338237
17. the subject has a resting heart rate > 110 bpm
Description

heart frequency

Type de données

boolean

Alias
UMLS CUI [1]
C0018810
18. the subject has thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e., anemia as determined by the investigator which would require transfusion)
Description

thrombocyt count | anemia

Type de données

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0002871
19. the subject is actively enrolled in a concurrent clinical study of an investigational drug or investigational device (study specifics may be reviewed with the sponsor prior to enrollment to confirm a concurrent study will not interfere with the outcomes of this study)
Description

concurrent study enrollment

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
20. the subject participated in any of the following studies: protect af, cap registry, or prevail. if the subject received a subject id number for a prior watchman study, the subject may not be enrolled. protect af control subjects may be considered for participation if they have completed 5 year follow up
Description

study participation

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
21. the subject is pregnant or pregnancy is planned during the course of the investigation
Description

pregnancy | pregnancy planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
22. the subject has a life expectancy of less than two years
Description

life expactancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
23. the subject is unable to complete follow-up visits for the duration of the study
Description

unable to complete follow-up visits

Type de données

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C1299582
1. the subject has lvef < 30%
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
2. the subject has intracardiac thrombus or dense spontaneous echo contrast as visualized by tee and determined by the echocardiographer within 2 days prior to implant
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0876998
UMLS CUI [2]
C0206054
3. the subject has an existing pericardial effusion > 2mm
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0031039
4. the subject has a high risk patent foramen ovale (pfo) with an atrial septal aneurysm excursion > 15mm or length > 15mm
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0016522
UMLS CUI [2]
C0521533
5. the subject has a high risk pfo with a large shunt defined as early, within 3 beats or substantial passage of bubbles
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1,1]
C0016522
UMLS CUI [1,2]
C0332167
6. the subject has significant mitral valve stenosis (i.e., mv <1.5 cm2)
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0026269
7. the subject has complex atheroma with mobile plaque of the descending aorta or aortic arch
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0155733
8. the subject has a cardiac tumor
Description

a subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via tte and tee) are met:

Type de données

boolean

Alias
UMLS CUI [1]
C0018809
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Similar models

Eligibility Atrial Fibrillation NCT01760291

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
age
Item
1. the subject is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
paroxysmal, persistent, or permanent non- valvular atrial fibrillation | non- valvular atrial fibrilliation
Item
2. the subject has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
C0004238 (UMLS CUI [4,1])
C0018826 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
warfarin therapy eglibility
Item
3. the subject is eligible for long-term warfarin therapy
boolean
C0043031 (UMLS CUI [1])
chads2 score
Item
4. the subject has a calculated chads2 score of 2 or greater;
boolean
C2585876 (UMLS CUI [1])
warfarin required
Item
subjects requiring warfarin therapy
boolean
C0043031 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
age
Item
the subject is a female age 75 or older
boolean
C0001779 (UMLS CUI [1])
left ventricular ejection fraction
Item
the subject has a baseline left ventricular ejection fraction (lvef) > 30% and < 35%
boolean
C0428772 (UMLS CUI [1])
age | diabetes | coronary artery disease
Item
the subject is age 65-74 and has diabetes or coronary artery disease
boolean
C0001779 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
age | congestice heart failure
Item
the subject is age 65 or greater and has documented congestive heart failure
boolean
C0001779 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
consent
Item
5. the subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
follow up
Item
6. the subject is able and willing to return for required follow-up visits and examinations
boolean
C1522577 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
warfarin
Item
1. the subject requires long-term warfarin therapy (i.e., even if the device is implanted, the subjects would not be eligible to discontinue warfarin due to other medical conditions requiring chronic warfarin therapy). additionally, a subject with any of the following is excluded:
boolean
C0043031 (UMLS CUI [1])
thrombosis | age
Item
thrombosis occurring at a young age (<40 years old)
boolean
C0040053 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
idiopathic venous thromboembolism | recurrent venous thromboembolism
Item
idiopathic or recurrent venous thromboembolism
boolean
C1861172 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C1861172 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
thrombosis at unusual site
Item
thrombosis at an unusual site (i.e., cerebral veins, hepatic veins,renal veins, inferior vena cava, mesenteric veins)
boolean
C4086711 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C2700116 (UMLS CUI [1,3])
inherited prothrombotic disorder
Item
family history of venous thromboembolism or of inherited prothrombotic disorder
boolean
C0314657 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
therapy resistant thrombosis
Item
recurrence or extension of thrombosis while adequately anticoagulated
boolean
C0040053 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
warfarin contraindication
Item
2. the subject is contraindicated for warfarin therapy or cannot tolerate long-term warfarin therapy
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
aspirin contraindication | aspirin allergy
Item
3. the subject is contraindicated or allergic to aspirin
boolean
C0004057 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
antiplatelet therapy
Item
4. the subject is indicated for antiplatelet therapy other than aspirin (for example, a subject indicated for clopidogrel, prasugrel, ticlopidine or ticagrelor due to des is excluded from enrollment during the dosing regimen). a subject completing a course of antiplatelet therapy may be enrolled after a 7 day washout period
boolean
C1096021 (UMLS CUI [1])
surgical procedure
Item
5. the subject had any interventional or surgical procedure within 30 days prior to enrollment or is planning to have an interventional or surgical procedure in the time between the watchman device implant and 45-day tee (e.g., cardioversion, ablation, cataract surgery, dental surgery)
boolean
C0543467 (UMLS CUI [1])
stroke | tia
Item
6. the subject had a prior stroke or tia within the 90 days prior to enrollment
boolean
C3844446 (UMLS CUI [1])
myocardial infarction
Item
7. the subject has had an mi within 90 days prior to enrollment
boolean
C0027051 (UMLS CUI [1])
atrial septal repair
Item
8. the subject has a history of atrial septal repair or has an asd/pfo device
boolean
C0189965 (UMLS CUI [1])
mechanical valve implant
Item
9. the subject has an implanted mechanical valve prosthesis
boolean
C4062429 (UMLS CUI [1])
ID.27
Item
10. the subject suffers from new york heart association class iv congestive heart failure at the time of enrollment
boolean
stenosis
Item
11. the subject has symptomatic carotid disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual tia evidenced by amaurosis fugax, ipsilateral hemispheric tias or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% stenosis
boolean
C0007282 (UMLS CUI [1])
atrial fibrillation single event
Item
12. the subject's af is defined by a single occurrence of af
boolean
C0004238 (UMLS CUI [1,1])
C1948045 (UMLS CUI [1,2])
transient atrial fibrilliation
Item
13. the subject had a transient case of af (i.e., secondary to cabg, interventional procedure, etc.)
boolean
C0004238 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
left atrial appendage obliterated
Item
14. the subject's left atrial appendage is obliterated
boolean
C0225860 (UMLS CUI [1,1])
C0598782 (UMLS CUI [1,2])
C1293136 (UMLS CUI [1,3])
heart transplantation
Item
15. the subject has undergone heart transplantation
boolean
C0018823 (UMLS CUI [1])
antibiotic treatment
Item
16. the subject is currently treated with antibiotics for an active infection
boolean
C0338237 (UMLS CUI [1])
heart frequency
Item
17. the subject has a resting heart rate > 110 bpm
boolean
C0018810 (UMLS CUI [1])
thrombocyt count | anemia
Item
18. the subject has thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e., anemia as determined by the investigator which would require transfusion)
boolean
C0005821 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
concurrent study enrollment
Item
19. the subject is actively enrolled in a concurrent clinical study of an investigational drug or investigational device (study specifics may be reviewed with the sponsor prior to enrollment to confirm a concurrent study will not interfere with the outcomes of this study)
boolean
C2348568 (UMLS CUI [1])
study participation
Item
20. the subject participated in any of the following studies: protect af, cap registry, or prevail. if the subject received a subject id number for a prior watchman study, the subject may not be enrolled. protect af control subjects may be considered for participation if they have completed 5 year follow up
boolean
C2348568 (UMLS CUI [1])
pregnancy | pregnancy planned
Item
21. the subject is pregnant or pregnancy is planned during the course of the investigation
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
life expactancy
Item
22. the subject has a life expectancy of less than two years
boolean
C0023671 (UMLS CUI [1])
unable to complete follow-up visits
Item
23. the subject is unable to complete follow-up visits for the duration of the study
boolean
C0589121 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
left ventricular ejection fraction
Item
1. the subject has lvef < 30%
boolean
C0428772 (UMLS CUI [1])
intracardiac thrombus
Item
2. the subject has intracardiac thrombus or dense spontaneous echo contrast as visualized by tee and determined by the echocardiographer within 2 days prior to implant
boolean
C0876998 (UMLS CUI [1])
C0206054 (UMLS CUI [2])
pericardial effusion
Item
3. the subject has an existing pericardial effusion > 2mm
boolean
C0031039 (UMLS CUI [1])
patent foramen ovale | atrial septum excursion
Item
4. the subject has a high risk patent foramen ovale (pfo) with an atrial septal aneurysm excursion > 15mm or length > 15mm
boolean
C0016522 (UMLS CUI [1])
C0521533 (UMLS CUI [2])
high risk pfo
Item
5. the subject has a high risk pfo with a large shunt defined as early, within 3 beats or substantial passage of bubbles
boolean
C0016522 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
mitral valve stenosis
Item
6. the subject has significant mitral valve stenosis (i.e., mv <1.5 cm2)
boolean
C0026269 (UMLS CUI [1])
atherosclerose
Item
7. the subject has complex atheroma with mobile plaque of the descending aorta or aortic arch
boolean
C0155733 (UMLS CUI [1])
cardiac tumor
Item
8. the subject has a cardiac tumor
boolean
C0018809 (UMLS CUI [1])
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