ID

15195

Description

Trajectory Changes of Coronary Sinus Lead Tip and Cardiac Resynchronization Therapy Outcome; ODM derived from: https://clinicaltrials.gov/show/NCT02340546

Link

https://clinicaltrials.gov/show/NCT02340546

Keywords

Versions (1)
  1. 5/22/16 5/22/16 -
Uploaded on

May 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02340546

English

Eligibility Heart Failure NCT02340546

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent;
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. chronic systolic heart failure recognized for more than 6 months, with left ventricular systolic disfunction (ejection fraction ≤ 35%) and nyha ii-iii or ambulatory iv class symptoms despite optimal medical treatment;
Description

Chronic systolic heart failure | Left ventricular systolic dysfunction | Left ventricular ejection fraction | New York Heart Association Classification | Therapeutic procedure Optimal

Data type

boolean

Alias
UMLS CUI [1]
C1135194
UMLS CUI [2]
C1277187
UMLS CUI [3]
C0428772
UMLS CUI [4]
C1275491
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C2698651
3. qrs complex on the surface electrocardiogram with left bundle branch block morphology and duration ≥ 120 ms, either typical or atypical or induced by right ventricular pacing due to stable chronic advanced atrio-ventricular block; qrs with with non-specific intraventricular delay lasting ≥ 150 ms;
Description

Electrocardiography QRS complex | Left Bundle-Branch Block Morphology | QRS complex duration | Cardiac pacing Right ventricle | Atrioventricular Block Advanced chronic Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0429097
UMLS CUI [2,1]
C0023211
UMLS CUI [2,2]
C0332437
UMLS CUI [3]
C0429025
UMLS CUI [4,1]
C0199640
UMLS CUI [4,2]
C0225883
UMLS CUI [5,1]
C0004245
UMLS CUI [5,2]
C0205179
UMLS CUI [5,3]
C0205191
UMLS CUI [5,4]
C0205360
4. a regular ventricular rhythm, either with spontaneous atrio-ventricular conduction or with ventricular pacing via a chronically implanted antibradycardia device; with sinus rhythm unless atrial fibrillation is permanent and associated with a permanent high-degree atrio-ventricular block with a spontaneous ventricular rate constantly ≤
Description

Idioventricular rhythm Regular | Atrioventricular Conduction Spontaneous | Intraventricular pacing | Implant Against Bradycardia | Sinus rhythm | Permanent atrial fibrillation | High grade atrioventricular block | Ventricular rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0700363
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C3831454
UMLS CUI [2,2]
C0205359
UMLS CUI [3]
C0199648
UMLS CUI [4,1]
C0021102
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0428977
UMLS CUI [5]
C0232201
UMLS CUI [6]
C2586056
UMLS CUI [7]
C2363939
UMLS CUI [8]
C2189285
45 beats per minute;
Description

ventricular rate Beats per minute

Data type

boolean

Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0439385
5. no concomitant bradyarrhythmias being per se an indication for new implant ventricular pacing; upgrade to cardiac resynchronization therapy only if a previous pacemaker or implantable cardioverter-defibrillator was implanted more than 6 months previously;
Description

Bradyarrhythmia Simultaneous | Intraventricular pacing | Cardiac Resynchronization Therapy | Artificial cardiac pacemaker | Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C0079035
UMLS CUI [1,2]
C0521115
UMLS CUI [2]
C0199648
UMLS CUI [3]
C1167956
UMLS CUI [4]
C0030163
UMLS CUI [5]
C0162589
6. a stable clinical and hemodynamic condition during cardiac resynchronization therapy device implant, and at the acquisition time heat rate between 50 and 100 beats per minute and respiratory rate ≤ 25 breaths per minute;
Description

medical condition Stable status | Hemodynamics Stable status | Implantation Cardiac Resynchronization Therapy Devices | Ventricular Heart Rate | Respiratory rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0019010
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0021107
UMLS CUI [3,2]
C2936377
UMLS CUI [4]
C1883530
UMLS CUI [5]
C0231832
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to give informed consent;
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. occurrence of myocardial infarction, valve repair or surgery, or coronary revascularization in the past 6 months;
Description

Myocardial Infarction | Repair of heart valve | Operative Surgical Procedures Heart Valves | Coronary revascularisation

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0190112
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0018826
UMLS CUI [4]
C0877341
3. any arrhythmia at the acquisition time which frequently alters the regularity of a minimum of five consecutive heart beats;
Description

Cardiac Arrhythmia | Irregular heart beat

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0237314
4. participation in any other competing clinical study, with the exception of registries ruled by national health service authorities or agencies, and observational studies/registries which are not conflicting and do not interfere with any of the following aspects:
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
1. the program of procedures/assessments requested by the present study;
Description

Study Subject Participation Status Interferes with Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
2. the outcome of the present study due to the requirement of medical treatments or interventions which are able to modify the clinical conditions of patients.
Description

Study Subject Participation Status Affecting research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
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Similar models

Eligibility Heart Failure NCT02340546

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. informed consent;
boolean
C0021430 (UMLS CUI [1])
Chronic systolic heart failure | Left ventricular systolic dysfunction | Left ventricular ejection fraction | New York Heart Association Classification | Therapeutic procedure Optimal
Item
2. chronic systolic heart failure recognized for more than 6 months, with left ventricular systolic disfunction (ejection fraction ≤ 35%) and nyha ii-iii or ambulatory iv class symptoms despite optimal medical treatment;
boolean
C1135194 (UMLS CUI [1])
C1277187 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
Electrocardiography QRS complex | Left Bundle-Branch Block Morphology | QRS complex duration | Cardiac pacing Right ventricle | Atrioventricular Block Advanced chronic Stable status
Item
3. qrs complex on the surface electrocardiogram with left bundle branch block morphology and duration ≥ 120 ms, either typical or atypical or induced by right ventricular pacing due to stable chronic advanced atrio-ventricular block; qrs with with non-specific intraventricular delay lasting ≥ 150 ms;
boolean
C1623258 (UMLS CUI [1,1])
C0429097 (UMLS CUI [1,2])
C0023211 (UMLS CUI [2,1])
C0332437 (UMLS CUI [2,2])
C0429025 (UMLS CUI [3])
C0199640 (UMLS CUI [4,1])
C0225883 (UMLS CUI [4,2])
C0004245 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C0205191 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
Idioventricular rhythm Regular | Atrioventricular Conduction Spontaneous | Intraventricular pacing | Implant Against Bradycardia | Sinus rhythm | Permanent atrial fibrillation | High grade atrioventricular block | Ventricular rate
Item
4. a regular ventricular rhythm, either with spontaneous atrio-ventricular conduction or with ventricular pacing via a chronically implanted antibradycardia device; with sinus rhythm unless atrial fibrillation is permanent and associated with a permanent high-degree atrio-ventricular block with a spontaneous ventricular rate constantly ≤
boolean
C0700363 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3831454 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0199648 (UMLS CUI [3])
C0021102 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0428977 (UMLS CUI [4,3])
C0232201 (UMLS CUI [5])
C2586056 (UMLS CUI [6])
C2363939 (UMLS CUI [7])
C2189285 (UMLS CUI [8])
ventricular rate Beats per minute
Item
45 beats per minute;
boolean
C2189285 (UMLS CUI [1,1])
C0439385 (UMLS CUI [1,2])
Bradyarrhythmia Simultaneous | Intraventricular pacing | Cardiac Resynchronization Therapy | Artificial cardiac pacemaker | Implantable defibrillator
Item
5. no concomitant bradyarrhythmias being per se an indication for new implant ventricular pacing; upgrade to cardiac resynchronization therapy only if a previous pacemaker or implantable cardioverter-defibrillator was implanted more than 6 months previously;
boolean
C0079035 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0199648 (UMLS CUI [2])
C1167956 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C0162589 (UMLS CUI [5])
medical condition Stable status | Hemodynamics Stable status | Implantation Cardiac Resynchronization Therapy Devices | Ventricular Heart Rate | Respiratory rate
Item
6. a stable clinical and hemodynamic condition during cardiac resynchronization therapy device implant, and at the acquisition time heat rate between 50 and 100 beats per minute and respiratory rate ≤ 25 breaths per minute;
boolean
C1699700 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0019010 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0021107 (UMLS CUI [3,1])
C2936377 (UMLS CUI [3,2])
C1883530 (UMLS CUI [4])
C0231832 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
1. inability to give informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Myocardial Infarction | Repair of heart valve | Operative Surgical Procedures Heart Valves | Coronary revascularisation
Item
2. occurrence of myocardial infarction, valve repair or surgery, or coronary revascularization in the past 6 months;
boolean
C0027051 (UMLS CUI [1])
C0190112 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0018826 (UMLS CUI [3,2])
C0877341 (UMLS CUI [4])
Cardiac Arrhythmia | Irregular heart beat
Item
3. any arrhythmia at the acquisition time which frequently alters the regularity of a minimum of five consecutive heart beats;
boolean
C0003811 (UMLS CUI [1])
C0237314 (UMLS CUI [2])
Study Subject Participation Status
Item
4. participation in any other competing clinical study, with the exception of registries ruled by national health service authorities or agencies, and observational studies/registries which are not conflicting and do not interfere with any of the following aspects:
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Interferes with Study Protocol
Item
1. the program of procedures/assessments requested by the present study;
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Study Subject Participation Status Affecting research results
Item
2. the outcome of the present study due to the requirement of medical treatments or interventions which are able to modify the clinical conditions of patients.
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
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