ID

15185

Beskrivning

Continued Access Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D (CAS RESPOND CRT); ODM derived from: https://clinicaltrials.gov/show/NCT02374801

Länk

https://clinicaltrials.gov/show/NCT02374801

Nyckelord

Versioner (1)
  1. 2016-05-21 2016-05-21 -
Uppladdad den

21 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure (NYHA Class III and Ambulatory IV) NCT02374801

Engelsk

Eligibility Heart Failure (NYHA Class III and Ambulatory IV) NCT02374801

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet all the following criteria at the time of enrollment may be included:
Beskrivning

Criteria Following

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332282
1. patient with a class i and iia indication for implantation of a crt-d device according to current available guidelines
Beskrivning

New York Heart Association Classification | Indication Implantation of CRT-D | Guidelines

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1135480
UMLS CUI [3]
C0162791
2. moderate/severe hf (nyha class iii or ambulatory iv)
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
3. lvef ≤ 35 %
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
4. lbbb: qrs ≥ 120 ms ; non-lbbb : qrs ≥ 150 ms
Beskrivning

Left Bundle-Branch Block QRS complex duration | Electrocardiogram QRS complex duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023211
UMLS CUI [1,2]
C0429025
UMLS CUI [2,1]
C0013798
UMLS CUI [2,2]
C0429025
5. on a stable optimal drug regimen
Beskrivning

Medication regimen Stable status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237125
UMLS CUI [1,2]
C0205360
6. patient is in sinus rhythm at the time of signing the informed consent
Beskrivning

Sinus rhythm Time Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0021430
7. signed and dated informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any one of these criteria will be excluded from the investigation:
Beskrivning

Criteria Following

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332282
1. ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrollment
Beskrivning

Tachycardia, Ventricular | Acute myocardial infarction | Digitalis intoxication (NOS) | Drowning | Electrocution | Electrolyte imbalance | Hypoxia | Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2]
C0155626
UMLS CUI [3]
C0151595
UMLS CUI [4]
C0013142
UMLS CUI [5]
C0277644
UMLS CUI [6]
C0342579
UMLS CUI [7]
C0242184
UMLS CUI [8]
C0243026
2. incessant ventricular tachyarrhythmia
Beskrivning

Incessant ventricular tachycardia

Datatyp

boolean

Alias
UMLS CUI [1]
C2363809
3. unstable angina, or mi, cabg, or ptca within the past 4 weeks
Beskrivning

Angina, Unstable | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0010055
UMLS CUI [4]
C2936173
4. correctable valvular disease that is the primary cause of heart failure
Beskrivning

Valvular disease Etiology aspects Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0018801
5. recent cva or tia (within the previous 3 months)
Beskrivning

Cerebrovascular accident Recent | Transient Ischemic Attack Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0007787
UMLS CUI [2,2]
C0332185
6. persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month**
Beskrivning

Atrial arrhythmia persistent | Atrial arrhythmia Permanent | ATRIAL FIBRILLATION CARDIOVERSION

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0085611
UMLS CUI [2,2]
C0205355
UMLS CUI [3]
C0741278
7. post heart transplant (patients who are waiting for a heart transplant are allowed in the study)
Beskrivning

Heart Transplantation Post

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0687676
8. renal failure (gfr<15 ml/min/1.73m2) or on dialysis
Beskrivning

Kidney Failure | Glomerular Filtration Rate | Dialysis procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0017654
UMLS CUI [3]
C0011946
9. previous implant with a crt- p or crt-d device
Beskrivning

Implantation procedure Previous | Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C1737639
UMLS CUI [3]
C1736558
10. concurrent implant with another pacemaker or icd system in which all or some of the components will not be extracted and/or utilized in the new system. previously implanted ra leads must be removed prior to implant of the sonrtip lead.
Beskrivning

Implantation procedure Concurrent | Artificial cardiac pacemaker | Implantable defibrillator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0162589
11. already included in another clinical study that could confound the results of this study
Beskrivning

Study Subject Participation Status Affecting research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
12. life expectancy less than 1 year
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
13. inability to understand the purpose of the study or to understand and complete the qol questionnaire
Beskrivning

Study Protocol Comprehension | Quality of life scale Questionnaires Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [2,1]
C0451401
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0205197
14. unavailability for scheduled follow-up or refusal to cooperate
Beskrivning

Unavailability follow-up | Cooperation Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686905
UMLS CUI [1,2]
C1522577
UMLS CUI [2,1]
C0392337
UMLS CUI [2,2]
C1705116
15. sensitivity to 1 mg dexamethasone sodium phosphate (dsp)
Beskrivning

Hypersensitivity Dexamethasone sodium phosphate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0113286
16. age of less than 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
17. pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
18. substance addiction or abuse
Beskrivning

Substance Dependence | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
19. under guardianship
Beskrivning

guardianship

Datatyp

boolean

Alias
UMLS CUI [1]
C0870627
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Similar models

Eligibility Heart Failure (NYHA Class III and Ambulatory IV) NCT02374801

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Following
Item
patients who meet all the following criteria at the time of enrollment may be included:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
New York Heart Association Classification | Indication Implantation of CRT-D | Guidelines
Item
1. patient with a class i and iia indication for implantation of a crt-d device according to current available guidelines
boolean
C1275491 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
C0162791 (UMLS CUI [3])
New York Heart Association Classification
Item
2. moderate/severe hf (nyha class iii or ambulatory iv)
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
3. lvef ≤ 35 %
boolean
C0428772 (UMLS CUI [1])
Left Bundle-Branch Block QRS complex duration | Electrocardiogram QRS complex duration
Item
4. lbbb: qrs ≥ 120 ms ; non-lbbb : qrs ≥ 150 ms
boolean
C0023211 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0013798 (UMLS CUI [2,1])
C0429025 (UMLS CUI [2,2])
Medication regimen Stable status
Item
5. on a stable optimal drug regimen
boolean
C0237125 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Sinus rhythm Time Informed Consent
Item
6. patient is in sinus rhythm at the time of signing the informed consent
boolean
C0232201 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Informed Consent
Item
7. signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Following
Item
patients who meet any one of these criteria will be excluded from the investigation:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
Tachycardia, Ventricular | Acute myocardial infarction | Digitalis intoxication (NOS) | Drowning | Electrocution | Electrolyte imbalance | Hypoxia | Sepsis
Item
1. ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrollment
boolean
C0042514 (UMLS CUI [1])
C0155626 (UMLS CUI [2])
C0151595 (UMLS CUI [3])
C0013142 (UMLS CUI [4])
C0277644 (UMLS CUI [5])
C0342579 (UMLS CUI [6])
C0242184 (UMLS CUI [7])
C0243026 (UMLS CUI [8])
Incessant ventricular tachycardia
Item
2. incessant ventricular tachyarrhythmia
boolean
C2363809 (UMLS CUI [1])
Angina, Unstable | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty
Item
3. unstable angina, or mi, cabg, or ptca within the past 4 weeks
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
Valvular disease Etiology aspects Heart failure
Item
4. correctable valvular disease that is the primary cause of heart failure
boolean
C3258293 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Cerebrovascular accident Recent | Transient Ischemic Attack Recent
Item
5. recent cva or tia (within the previous 3 months)
boolean
C0038454 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0007787 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Atrial arrhythmia persistent | Atrial arrhythmia Permanent | ATRIAL FIBRILLATION CARDIOVERSION
Item
6. persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month**
boolean
C0085611 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0085611 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C0741278 (UMLS CUI [3])
Heart Transplantation Post
Item
7. post heart transplant (patients who are waiting for a heart transplant are allowed in the study)
boolean
C0018823 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
Kidney Failure | Glomerular Filtration Rate | Dialysis procedure
Item
8. renal failure (gfr<15 ml/min/1.73m2) or on dialysis
boolean
C0035078 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Implantation procedure Previous | Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Item
9. previous implant with a crt- p or crt-d device
boolean
C0021107 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1737639 (UMLS CUI [2])
C1736558 (UMLS CUI [3])
Implantation procedure Concurrent | Artificial cardiac pacemaker | Implantable defibrillator
Item
10. concurrent implant with another pacemaker or icd system in which all or some of the components will not be extracted and/or utilized in the new system. previously implanted ra leads must be removed prior to implant of the sonrtip lead.
boolean
C0021107 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0162589 (UMLS CUI [3])
Study Subject Participation Status Affecting research results
Item
11. already included in another clinical study that could confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Life Expectancy
Item
12. life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Study Protocol Comprehension | Quality of life scale Questionnaires Completion
Item
13. inability to understand the purpose of the study or to understand and complete the qol questionnaire
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0451401 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Unavailability follow-up | Cooperation Refused
Item
14. unavailability for scheduled follow-up or refusal to cooperate
boolean
C0686905 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C0392337 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Hypersensitivity Dexamethasone sodium phosphate
Item
15. sensitivity to 1 mg dexamethasone sodium phosphate (dsp)
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
Age
Item
16. age of less than 18 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
17. pregnancy
boolean
C0032961 (UMLS CUI [1])
Substance Dependence | Substance Use Disorders
Item
18. substance addiction or abuse
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
guardianship
Item
19. under guardianship
boolean
C0870627 (UMLS CUI [1])
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