ID

39397

Description

QuickOpt Chronic Study; ODM derived from: https://clinicaltrials.gov/show/NCT01172067

Link

https://clinicaltrials.gov/show/NCT01172067

Keywords

Versions (1)
  1. 1/7/20 1/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01172067

English

Eligibility Heart Failure NCT01172067

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
• patient meets current crt-p indications and be implanted with an sjm crt-p device with v-v timing and a compatible lead system
Description

Indication Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Implantation Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1737639
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C1737639
UMLS CUI [3]
C3846158
patient is able to provide written informed consent for study participation
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• patient has limited intrinsic atrial activity (≤ 40 bpm)
Description

Activity Atrial Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0439801
patient has persistent or permanent af
Description

Persistent atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
patient has a 2o or 3o heart block
Description

Second degree atrioventricular block | Complete atrioventricular block

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
patient's life expectancy is <12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient is <18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient is on iv inotropic agents
Description

Inotropic agent Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
patients who are ongoing other devices or agents study
Description

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
patients with heart transplanted or waiting for heart transplant
Description

Heart Transplantation | Patient waiting for Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2,1]
C0542399
UMLS CUI [2,2]
C0018823
patients with hypertrophic and obstructive cardiomyopathy
Description

Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
Description

Aortic Valve Stenosis Severe | Mitral Valve Stenosis Severe | Aortic Valve Insufficiency Severe | Mitral Valve Insufficiency Severe | Replacement Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0026269
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0003504
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0026266
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C1410969
UMLS CUI [5,2]
C0332197
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Similar models

Eligibility Heart Failure NCT01172067

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Implantation Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Other Coding
Item
• patient meets current crt-p indications and be implanted with an sjm crt-p device with v-v timing and a compatible lead system
boolean
C3146298 (UMLS CUI [1,1])
C1737639 (UMLS CUI [1,2])
C0021107 (UMLS CUI [2,1])
C1737639 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
Informed Consent
Item
patient is able to provide written informed consent for study participation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Activity Atrial Limited
Item
• patient has limited intrinsic atrial activity (≤ 40 bpm)
boolean
C0205177 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
patient has persistent or permanent af
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Second degree atrioventricular block | Complete atrioventricular block
Item
patient has a 2o or 3o heart block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Life Expectancy
Item
patient's life expectancy is <12 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
patient is <18 years old
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
patient is pregnant
boolean
C0032961 (UMLS CUI [1])
Inotropic agent Intravenous
Item
patient is on iv inotropic agents
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
patients who are ongoing other devices or agents study
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Heart Transplantation | Patient waiting for Heart Transplantation
Item
patients with heart transplanted or waiting for heart transplant
boolean
C0018823 (UMLS CUI [1])
C0542399 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
Hypertrophic Cardiomyopathy
Item
patients with hypertrophic and obstructive cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
Aortic Valve Stenosis Severe | Mitral Valve Stenosis Severe | Aortic Valve Insufficiency Severe | Mitral Valve Insufficiency Severe | Replacement Absent
Item
patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
boolean
C0003507 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0026269 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0003504 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0026266 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1410969 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
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