ID

16843

Description

Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead; ODM derived from: https://clinicaltrials.gov/show/NCT00158938

Link

https://clinicaltrials.gov/show/NCT00158938

Keywords

Versions (1)
  1. 8/10/16 8/10/16 -
Uploaded on

August 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00158938

English

Eligibility Congestive Heart Failure NCT00158938

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
Description

Heart failure Moderate Symptomatic | Heart failure Severe Symptomatic | New York Heart Association Classification | Ventricular Dysfunction, Left | Cardiac ejection fraction | QRS complex duration | Heart failure Pharmacotherapy Stable Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0231220
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0231220
UMLS CUI [3]
C1275491
UMLS CUI [4]
C0242698
UMLS CUI [5]
C0232174
UMLS CUI [6]
C0429025
UMLS CUI [7,1]
C0018801
UMLS CUI [7,2]
C0013216
UMLS CUI [7,3]
C0205360
UMLS CUI [7,4]
C2698651
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
age 18 or above, or of legal age to give informed consent specific to state and national law.
Description

Age | Informed Consent Age Legal

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C1301860
willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol.
Description

Informed Consent | Device implant Capability | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0948629
UMLS CUI [2,2]
C2698977
UMLS CUI [3]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
Description

Hypersensitivity dexamethasone acetate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0057598
previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement.
Description

Cardiac Resynchronization Therapy | Lead, coronary venous | Ventricular Lead Left Placement Attempt

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C1145020
UMLS CUI [3,1]
C2825199
UMLS CUI [3,2]
C0205091
UMLS CUI [3,3]
C0589567
UMLS CUI [3,4]
C1516084
pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
Description

Lead, pacemaker/cardioverter-defibrillator combination (implantable) Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0993798
UMLS CUI [1,2]
C2347662
requiring dialysis.
Description

Dialysis procedure Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0686904
a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
Description

Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
Description

Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy secondary to infiltrations | Amyloidosis | Sarcoidosis

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0264839
UMLS CUI [3]
C0002726
UMLS CUI [4]
C0036202
a documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
Description

Life Expectancy | Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C1517001
enrolled in any concurrent study, without prior guidant written approval, that may confound the results of this study.
Description

Study Subject Participation Status Interferes with research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
have a mechanical tricuspid heart valve.
Description

Mechanical heart valve Tricuspid

Data type

boolean

Alias
UMLS CUI [1,1]
C0493527
UMLS CUI [1,2]
C0443327
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Similar models

Eligibility Congestive Heart Failure NCT00158938

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Moderate Symptomatic | Heart failure Severe Symptomatic | New York Heart Association Classification | Ventricular Dysfunction, Left | Cardiac ejection fraction | QRS complex duration | Heart failure Pharmacotherapy Stable Optimal
Item
moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C1275491 (UMLS CUI [3])
C0242698 (UMLS CUI [4])
C0232174 (UMLS CUI [5])
C0429025 (UMLS CUI [6])
C0018801 (UMLS CUI [7,1])
C0013216 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C2698651 (UMLS CUI [7,4])
Creatinine measurement, serum
Item
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment.
boolean
C0201976 (UMLS CUI [1])
Age | Informed Consent Age Legal
Item
age 18 or above, or of legal age to give informed consent specific to state and national law.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C1301860 (UMLS CUI [2,3])
Informed Consent | Device implant Capability | Protocol Compliance
Item
willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol.
boolean
C0021430 (UMLS CUI [1])
C0948629 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity dexamethasone acetate
Item
a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
Cardiac Resynchronization Therapy | Lead, coronary venous | Ventricular Lead Left Placement Attempt
Item
previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement.
boolean
C1167956 (UMLS CUI [1])
C1145020 (UMLS CUI [2])
C2825199 (UMLS CUI [3,1])
C0205091 (UMLS CUI [3,2])
C0589567 (UMLS CUI [3,3])
C1516084 (UMLS CUI [3,4])
Lead, pacemaker/cardioverter-defibrillator combination (implantable) Pre-existing
Item
pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
boolean
C0993798 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Dialysis procedure Patient need for
Item
requiring dialysis.
boolean
C0011946 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy secondary to infiltrations | Amyloidosis | Sarcoidosis
Item
hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
boolean
C0007194 (UMLS CUI [1])
C0264839 (UMLS CUI [2])
C0002726 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
Life Expectancy | Heart Transplantation Expected
Item
a documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
boolean
C0023671 (UMLS CUI [1])
C0018823 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with research results
Item
enrolled in any concurrent study, without prior guidant written approval, that may confound the results of this study.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Mechanical heart valve Tricuspid
Item
have a mechanical tricuspid heart valve.
boolean
C0493527 (UMLS CUI [1,1])
C0443327 (UMLS CUI [1,2])
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