ID

39529

Beskrivning

Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D; ODM derived from: https://clinicaltrials.gov/show/NCT01534234

Länk

https://clinicaltrials.gov/show/NCT01534234

Nyckelord

Versioner (1)
  1. 2020-01-23 2020-01-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NYHA Class III and Ambulatory IV NCT01534234

Engelsk

Eligibility Heart Failure NYHA Class III and Ambulatory IV NCT01534234

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient eligible with class i and iia indication for implantation of a crt-d device according to current available guidelines ;
Beskrivning

Indication Class Implantation of CRT-D

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C1135480
2. modere,severe hf (nyha class iii or ambulatory iv)
Beskrivning

Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1275491
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1561561
UMLS CUI [3,3]
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 duration | Left Bundle-Branch Block Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0023211
UMLS CUI [2]
C0429025
UMLS CUI [3,1]
C0023211
UMLS CUI [3,2]
C0332197
5. on a stable, optimal drug regimen
Beskrivning

Pharmacotherapy Optimal Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0205360
6. patient is in sinus rhythm at the time of enrollment;
Beskrivning

Sinus rhythm

Datatyp

boolean

Alias
UMLS CUI [1]
C0232201
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
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 enrolment;
Beskrivning

Tachycardia, Ventricular | Cause Transitory | Cause Reversible | Myocardial Infarction | Digitalis intoxication | Drowning | Electrocution | Electrolyte imbalance | Hypoxia | Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0205374
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0205343
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0151595
UMLS CUI [6]
C0013142
UMLS CUI [7]
C0277644
UMLS CUI [8]
C0342579
UMLS CUI [9]
C0242184
UMLS CUI [10]
C0243026
2. incessant ventricular tachyarrhythmia;
Beskrivning

Incessant ventricular tachycardia

Datatyp

boolean

Alias
UMLS CUI [1]
C2363809
3. unstable angina, or acute 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 Causing Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0678227
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

Status post Heart Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0018823
8. renal failure (gfr<15 ml/min/1.73m2) or on dialysis
Beskrivning

Kidney Failure | Glomerular Filtration Rate | Dialysis

Datatyp

boolean

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

Implantation of CRT-D Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0205156
10. concurrent implant with another pacemaker or icd (previously implanted pacemaker or icd devices or ra leads should be removed prior to implant with the paradym rf sonr crt-d);
Beskrivning

Artificial cardiac pacemaker Concurrent | Implantable defibrillator Concurrent |

Datatyp

boolean

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

Study Subject Participation Status | Clinical Trial | Interference Research results

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
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 Unable | Quality of life Questionnaire Comprehension Unable | Quality of life Questionnaire Completion Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0034380
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0162340
UMLS CUI [2,4]
C1299582
UMLS CUI [3,1]
C0034380
UMLS CUI [3,2]
C0034394
UMLS CUI [3,3]
C0205197
UMLS CUI [3,4]
C1299582
14. unavailability for scheduled follow-up or refusal to cooperate;
Beskrivning

Patient Unavailable Follow-up | Patient cooperation Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0686905
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1705116
15. sensitivity to 1 mg dexamethasone sodium phosphate (dsp)
Beskrivning

Hypersensitivity Dexamethasone sodium phosphate Dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0113286
UMLS CUI [1,3]
C0178602
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. drug addiction or abuse
Beskrivning

Drug Dependence | Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C1510472
UMLS CUI [2]
C0013146
19. under guardianship
Beskrivning

Patients Guardianship

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
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Similar models

Eligibility Heart Failure NYHA Class III and Ambulatory IV NCT01534234

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication Class Implantation of CRT-D
Item
1. patient eligible with class i and iia indication for implantation of a crt-d device according to current available guidelines ;
boolean
C3146298 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1135480 (UMLS CUI [1,3])
Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification
Item
2. modere,severe hf (nyha class iii or ambulatory iv)
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C1561561 (UMLS CUI [3,2])
C1275491 (UMLS CUI [3,3])
Left ventricular ejection fraction
Item
3. lvef ≤ 35 %
boolean
C0428772 (UMLS CUI [1])
Left Bundle-Branch Block | QRS duration | Left Bundle-Branch Block Absent
Item
4. lbbb: qrs ≥ 120 ms ; non-lbbb : qrs ≥ 150 ms
boolean
C0023211 (UMLS CUI [1])
C0429025 (UMLS CUI [2])
C0023211 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pharmacotherapy Optimal Stable
Item
5. on a stable, optimal drug regimen
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Sinus rhythm
Item
6. patient is in sinus rhythm at the time of enrollment;
boolean
C0232201 (UMLS CUI [1])
Informed Consent
Item
7. signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tachycardia, Ventricular | Cause Transitory | Cause Reversible | Myocardial Infarction | Digitalis intoxication | 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 enrolment;
boolean
C0042514 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0205374 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0151595 (UMLS CUI [5])
C0013142 (UMLS CUI [6])
C0277644 (UMLS CUI [7])
C0342579 (UMLS CUI [8])
C0242184 (UMLS CUI [9])
C0243026 (UMLS CUI [10])
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 acute 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 Causing Heart failure
Item
4. correctable valvular disease that is the primary cause of heart failure;
boolean
C3258293 (UMLS CUI [1,1])
C0678227 (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])
Status post Heart Transplantation
Item
7. post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
boolean
C0231290 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
Kidney Failure | Glomerular Filtration Rate | Dialysis
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 of CRT-D Previous
Item
9. previous implant with a crt/crt-d device;
boolean
C1135480 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Artificial cardiac pacemaker Concurrent | Implantable defibrillator Concurrent |
Item
10. concurrent implant with another pacemaker or icd (previously implanted pacemaker or icd devices or ra leads should be removed prior to implant with the paradym rf sonr crt-d);
boolean
C0030163 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial | Interference Research results
Item
11. already included in another clinical study that could confound the results of this study;
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0521102 (UMLS CUI [3,1])
C0683954 (UMLS CUI [3,2])
Life Expectancy
Item
12. life expectancy less than 1 year;
boolean
C0023671 (UMLS CUI [1])
Study Protocol Comprehension Unable | Quality of life Questionnaire Comprehension Unable | Quality of life Questionnaire Completion Unable
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])
C1299582 (UMLS CUI [1,3])
C0034380 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0034380 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
Patient Unavailable Follow-up | Patient cooperation Refused
Item
14. unavailability for scheduled follow-up or refusal to cooperate;
boolean
C0030705 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Hypersensitivity Dexamethasone sodium phosphate Dose
Item
15. sensitivity to 1 mg dexamethasone sodium phosphate (dsp)
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Age
Item
16. age of less than 18 years;
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
17. pregnancy
boolean
C0032961 (UMLS CUI [1])
Drug Dependence | Drug abuse
Item
18. drug addiction or abuse
boolean
C1510472 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Patients Guardianship
Item
19. under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
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