ID

39497

Beschrijving

Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01996397

Link

https://clinicaltrials.gov/show/NCT01996397

Trefwoorden

Versies (1)
  1. 19-01-20 19-01-20 -
Houder van rechten

See clinicaltrials.gov

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19 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01996397

Engels

Eligibility Heart Failure NCT01996397

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is indicated for crt or crt-d device according to current applicable esc/aha guidelines
Beschrijving

Indication Cardiac Resynchronization Therapy | Indication Implantation of CRT-D

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1167956
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1135480
subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). no documented af-episodes allowed during the last 2 weeks prior to inclusion.
Beschrijving

Sinus rhythm Stable | Atrial arrhythmia Duration | Episode of Atrial Fibrillation Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0085611
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0004238
UMLS CUI [3,3]
C0332197
subject receives optimal heart failure oral medical therapy (ace inhibitor and/or arb and beta blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
Beschrijving

Therapy Oral Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Pharmaceutical Preparations Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C2698651
UMLS CUI [1,4]
C0018801
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0304516
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0205360
subject (or the legal guardian) is willing to sign informed consent form
Beschrijving

Informed Consent | Informed Consent Legal Guardian

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
permanent atrial fibrillation/ flutter or tachycardia
Beschrijving

Permanent atrial fibrillation | Atrial Flutter Permanent | Atrial tachycardia Permanent

Datatype

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0205355
UMLS CUI [3,1]
C0546959
UMLS CUI [3,2]
C0205355
rbbb
Beschrijving

Right bundle branch block

Datatype

boolean

Alias
UMLS CUI [1]
C0085615
recent myocardial infarction (mi), within 40 days prior to enrollment. subject underwent coronary artery bypass graft (cabg) or valve surgery, within 90 days prior to enrollment
Beschrijving

Recent myocardial infarction | Coronary Artery Bypass Surgery | Valve Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C1998297
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C1186983
UMLS CUI [3,2]
C0543467
post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
Beschrijving

Status post Heart Transplantation | Patient on waiting list Transplantation | Transplantation Expected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0018823
UMLS CUI [2,1]
C0422768
UMLS CUI [2,2]
C0040732
UMLS CUI [3,1]
C0040732
UMLS CUI [3,2]
C1517001
implanted with a left ventricular assist device (lvad), or has reasonable probability (per investigator's discretion) of receiving a lvad in the next year
Beschrijving

Implantation of left ventricular assist device | Implantation of left ventricular assist device Expected

Datatype

boolean

Alias
UMLS CUI [1]
C0397130
UMLS CUI [2,1]
C0397130
UMLS CUI [2,2]
C1517001
on chronic renal dialysis, or with severe renal disease (defined as estimated glomerular filtration rate (equation provided by modification of diet in renal disease study): (egfr) < 30 ml/min/1.73m2)
Beschrijving

Dialysis chronic | Kidney Disease Severe | GFR estimation by MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C0743165
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2170215
on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
Beschrijving

Inotropic agent Infusion Heart failure | Infusion Stable times per week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0456698
severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)
Beschrijving

Aortic stenosis, severe | Valve Area | Valvular disease | Operative Surgical Procedure Expected

Datatype

boolean

Alias
UMLS CUI [1]
C3806272
UMLS CUI [2,1]
C1186983
UMLS CUI [2,2]
C0205146
UMLS CUI [3]
C3258293
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C1517001
complex and uncorrected congenital heart disease
Beschrijving

Complex congenital heart disease uncorrected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0744669
UMLS CUI [1,2]
C4072785
mechanical heart valve
Beschrijving

Mechanical heart valve

Datatype

boolean

Alias
UMLS CUI [1]
C0493527
breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
Beschrijving

Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
enrolled in one or more concurrent studies that would confound the results of this study
Beschrijving

Study Subject Participation Status | Clinical Trials Quantity | Interference Research results

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0683954
already implanted with pacemaker (crt, crt-d, icd) and needs replacement
Beschrijving

Pacemaker implant | Cardiac Resynchronization Therapy | Implantation of CRT-D | Implantable defibrillator | Replacement Needed

Datatype

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C1167956
UMLS CUI [3]
C1135480
UMLS CUI [4]
C0162589
UMLS CUI [5,1]
C0559956
UMLS CUI [5,2]
C0027552
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Similar models

Eligibility Heart Failure NCT01996397

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy | Indication Implantation of CRT-D
Item
subject is indicated for crt or crt-d device according to current applicable esc/aha guidelines
boolean
C3146298 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
Sinus rhythm Stable | Atrial arrhythmia Duration | Episode of Atrial Fibrillation Absent
Item
subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). no documented af-episodes allowed during the last 2 weeks prior to inclusion.
boolean
C0232201 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0085611 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Therapy Oral Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Pharmaceutical Preparations Stable
Item
subject receives optimal heart failure oral medical therapy (ace inhibitor and/or arb and beta blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
boolean
C0087111 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Informed Consent | Informed Consent Legal Guardian
Item
subject (or the legal guardian) is willing to sign informed consent form
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Permanent atrial fibrillation | Atrial Flutter Permanent | Atrial tachycardia Permanent
Item
permanent atrial fibrillation/ flutter or tachycardia
boolean
C2586056 (UMLS CUI [1])
C0004239 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C0546959 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
Right bundle branch block
Item
rbbb
boolean
C0085615 (UMLS CUI [1])
Recent myocardial infarction | Coronary Artery Bypass Surgery | Valve Surgery
Item
recent myocardial infarction (mi), within 40 days prior to enrollment. subject underwent coronary artery bypass graft (cabg) or valve surgery, within 90 days prior to enrollment
boolean
C1998297 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1186983 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Status post Heart Transplantation | Patient on waiting list Transplantation | Transplantation Expected
Item
post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
boolean
C0231290 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0422768 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C0040732 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Implantation of left ventricular assist device | Implantation of left ventricular assist device Expected
Item
implanted with a left ventricular assist device (lvad), or has reasonable probability (per investigator's discretion) of receiving a lvad in the next year
boolean
C0397130 (UMLS CUI [1])
C0397130 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Dialysis chronic | Kidney Disease Severe | GFR estimation by MDRD
Item
on chronic renal dialysis, or with severe renal disease (defined as estimated glomerular filtration rate (equation provided by modification of diet in renal disease study): (egfr) < 30 ml/min/1.73m2)
boolean
C0743165 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2170215 (UMLS CUI [3])
Inotropic agent Infusion Heart failure | Infusion Stable times per week
Item
on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
boolean
C0304509 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0574032 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0456698 (UMLS CUI [2,3])
Aortic stenosis, severe | Valve Area | Valvular disease | Operative Surgical Procedure Expected
Item
severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)
boolean
C3806272 (UMLS CUI [1])
C1186983 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C3258293 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Complex congenital heart disease uncorrected
Item
complex and uncorrected congenital heart disease
boolean
C0744669 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Mechanical heart valve
Item
mechanical heart valve
boolean
C0493527 (UMLS CUI [1])
Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
boolean
C0006147 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trials Quantity | Interference Research results
Item
enrolled in one or more concurrent studies that would confound the results of this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0683954 (UMLS CUI [3,2])
Pacemaker implant | Cardiac Resynchronization Therapy | Implantation of CRT-D | Implantable defibrillator | Replacement Needed
Item
already implanted with pacemaker (crt, crt-d, icd) and needs replacement
boolean
C0848753 (UMLS CUI [1])
C1167956 (UMLS CUI [2])
C1135480 (UMLS CUI [3])
C0162589 (UMLS CUI [4])
C0559956 (UMLS CUI [5,1])
C0027552 (UMLS CUI [5,2])
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