ID

39621

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01059175

Keywords

  1. 04/02/20 04/02/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

4 febbraio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01059175

Eligibility Heart Failure NCT01059175

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than 18 years
Descrizione

Age

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Stimulation biventricular Optimization | Therapy Optimization

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Stimulation Left ventricle Percentage | Threshold Left ventricle

Tipo di dati

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
Descrizione

Cardiac Resynchronization Therapy | Clinical status Unchanged | Clinical status Worsened

Tipo di dati

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
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

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

Lead Left ventricle | Location Great cardiac vein

Tipo di dati

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
Descrizione

Life Expectancy Due to Comorbidity | Comorbidity Except Cardiovascular Diseases

Tipo di dati

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
Descrizione

Dialysis chronic

Tipo di dati

boolean

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

Comorbidity Interferes with Research results

Tipo di dati

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
Descrizione

Systolic Pressure | Diastolic blood pressure | Therapy Optimal

Tipo di dati

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
Descrizione

Cerebrovascular accident | Myocardial Infarction | Angina, Unstable

Tipo di dati

boolean

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

Valvular disease | Correction Possible

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Pregnancy

Tipo di dati

boolean

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

Study Subject Participation Status | Research project

Tipo di dati

boolean

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

Similar models

Eligibility Heart Failure NCT01059175

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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