ID

39621

Description

Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01059175

Link

https://clinicaltrials.gov/show/NCT01059175

Keywords

Versions (1)
  1. 2/4/20 2/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01059175

English

Eligibility Heart Failure NCT01059175

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
recipient of a crt-p or crt-d system for greater than 6 for standard indications, including lv ejection fraction greater than 35 percent and new york heart association (nyha) functional class iii or iv
Description

Cardiac Resynchronization Therapy Pacemaker (CRT-P) Recipient | Implantation of CRT-D | Standard Indication | Left ventricular ejection fraction | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1737639
UMLS CUI [1,2]
C1709854
UMLS CUI [2]
C1135480
UMLS CUI [3,1]
C1442989
UMLS CUI [3,2]
C3146298
UMLS CUI [4]
C0428772
UMLS CUI [5]
C1275491
optimized biventricular stimulation and medical therapy since implantation of the system
Description

Stimulation biventricular Optimization | Therapy Optimization

Data type

boolean

Alias
UMLS CUI [1,1]
C1292856
UMLS CUI [1,2]
C0699808
UMLS CUI [1,3]
C2698650
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698650
presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
Description

Sinus rhythm Present | Atrial Fibrillation | Complete atrioventricular block Spontaneous | Complete atrioventricular block Induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0150312
UMLS CUI [2]
C0004238
UMLS CUI [3,1]
C0151517
UMLS CUI [3,2]
C0205359
UMLS CUI [4,1]
C0151517
UMLS CUI [4,2]
C0205263
greater than 93 percent lv stimulation since the last device interrogation, with a lv capture threshold less than 5.0 volts/0.5 milliseconds
Description

Stimulation Left ventricle Percentage | Threshold Left ventricle

Data type

boolean

Alias
UMLS CUI [1,1]
C1292856
UMLS CUI [1,2]
C0225897
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0449864
UMLS CUI [2,2]
C0225897
unchanged or worsened clinical status by crt, according to the hf composite endpoint described by m. packer, in absence of a reversible cause
Description

Cardiac Resynchronization Therapy | Clinical status Unchanged | Clinical status Worsened

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2,1]
C0449440
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C0449440
UMLS CUI [3,2]
C1457868
signature of a written, informed consent to participate in the trial
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
lv lead location in the great cardiac vein
Description

Lead Left ventricle | Location Great cardiac vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0181586
UMLS CUI [1,2]
C0225897
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0226659
life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
Description

Life Expectancy Due to Comorbidity | Comorbidity Except Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0007222
chronic renal dialysis
Description

Dialysis chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0205191
concomitant disorder which might interfere with the results of the v3 trial
Description

Comorbidity Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
blood systolic pressure greater than 180 millimeters of mercury (mmhg) or diastolic pressure greater than 95 mmhg despite optimal medical management
Description

Systolic Pressure | Diastolic blood pressure | Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2698651
history of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
Description

Cerebrovascular accident | Myocardial Infarction | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
presence of correctible valvular disease
Description

Valvular disease | Correction Possible

Data type

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C0332149
subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
Description

Follow-up Attend Unable | Protocol Compliance Unable | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
subject is pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
subject participates in another research project
Description

Study Subject Participation Status | Research project

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0700032
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Similar models

Eligibility Heart Failure NCT01059175

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater than 18 years
boolean
C0001779 (UMLS CUI [1])
Cardiac Resynchronization Therapy Pacemaker (CRT-P) Recipient | Implantation of CRT-D | Standard Indication | Left ventricular ejection fraction | New York Heart Association Classification
Item
recipient of a crt-p or crt-d system for greater than 6 for standard indications, including lv ejection fraction greater than 35 percent and new york heart association (nyha) functional class iii or iv
boolean
C1737639 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C1135480 (UMLS CUI [2])
C1442989 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
Stimulation biventricular Optimization | Therapy Optimization
Item
optimized biventricular stimulation and medical therapy since implantation of the system
boolean
C1292856 (UMLS CUI [1,1])
C0699808 (UMLS CUI [1,2])
C2698650 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C2698650 (UMLS CUI [2,2])
Sinus rhythm Present | Atrial Fibrillation | Complete atrioventricular block Spontaneous | Complete atrioventricular block Induced
Item
presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
boolean
C0232201 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C0151517 (UMLS CUI [3,1])
C0205359 (UMLS CUI [3,2])
C0151517 (UMLS CUI [4,1])
C0205263 (UMLS CUI [4,2])
Stimulation Left ventricle Percentage | Threshold Left ventricle
Item
greater than 93 percent lv stimulation since the last device interrogation, with a lv capture threshold less than 5.0 volts/0.5 milliseconds
boolean
C1292856 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0449864 (UMLS CUI [2,1])
C0225897 (UMLS CUI [2,2])
Cardiac Resynchronization Therapy | Clinical status Unchanged | Clinical status Worsened
Item
unchanged or worsened clinical status by crt, according to the hf composite endpoint described by m. packer, in absence of a reversible cause
boolean
C1167956 (UMLS CUI [1])
C0449440 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C0449440 (UMLS CUI [3,1])
C1457868 (UMLS CUI [3,2])
Informed Consent
Item
signature of a written, informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lead Left ventricle | Location Great cardiac vein
Item
lv lead location in the great cardiac vein
boolean
C0181586 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0226659 (UMLS CUI [2,2])
Life Expectancy Due to Comorbidity | Comorbidity Except Cardiovascular Diseases
Item
life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0007222 (UMLS CUI [2,3])
Dialysis chronic
Item
chronic renal dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Comorbidity Interferes with Research results
Item
concomitant disorder which might interfere with the results of the v3 trial
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Systolic Pressure | Diastolic blood pressure | Therapy Optimal
Item
blood systolic pressure greater than 180 millimeters of mercury (mmhg) or diastolic pressure greater than 95 mmhg despite optimal medical management
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
Cerebrovascular accident | Myocardial Infarction | Angina, Unstable
Item
history of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Valvular disease | Correction Possible
Item
presence of correctible valvular disease
boolean
C3258293 (UMLS CUI [1])
C1947976 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Follow-up Attend Unable | Protocol Compliance Unable | Informed Consent Unable
Item
subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
boolean
C3274571 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Pregnancy
Item
subject is pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Research project
Item
subject participates in another research project
boolean
C2348568 (UMLS CUI [1])
C0700032 (UMLS CUI [2])
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