ID

42841

Description

Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF; ODM derived from: https://clinicaltrials.gov/show/NCT00158951

Link

https://clinicaltrials.gov/show/NCT00158951

Keywords

Versions (2)
  1. 8/10/16 8/10/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00158951

English

Eligibility Congestive Heart Failure NCT00158951

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet the general indications for a crt-d device
Description

Indication General CRT-D device

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0205246
UMLS CUI [1,3]
C1736558
moderate or severe heart failure, defined as nyha class iii-iv despite optimal pharmacological heart failure therapy.
Description

Heart failure Moderate | Heart failure Severe | New York Heart Association Classification | Heart failure Pharmacotherapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1275491
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0013216
UMLS CUI [4,3]
C2698651
a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm, qrs duration ³ 150 ms, and pr interval £ 320 ms measured from any two leads, and a p-wave duration < 150 ms measured from lead v1
Description

12 lead ECG | Sinus rhythm | QRS duration | P-R interval | P wave duration

Data type

boolean

Alias
UMLS CUI [1]
C0430456
UMLS CUI [2]
C0232201
UMLS CUI [3]
C0429025
UMLS CUI [4]
C0429087
UMLS CUI [5]
C0429021
creatinine £ 2.5 mg/dl obtained no more than 14 days prior to enrollment
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
left ventricular ejection fraction £ 35% [measured by echo, multiple gated acquisition (muga) scan, cardiac catheterization, etc.] no more than 14 days prior to enrollment
Description

Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning | Cardiac Catheterization

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
UMLS CUI [4]
C0018795
willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
Description

Device implant Capability | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0948629
UMLS CUI [1,2]
C2698977
UMLS CUI [2]
C0525058
have a life expectancy of more than 180 days, per physician discretion
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
right bundle branch block morphology (per world health organization guidelines) on a 12-lead ecg obtained no more than 90 days prior to enrollment.
Description

Right bundle branch block morphology | 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0085615
UMLS CUI [1,2]
C0543482
UMLS CUI [2]
C0430456
have had previous cardiac resynchronization therapy, a previous coronary venous lead, or meet the general indications for antibradycardia pacing
Description

Cardiac Resynchronization Therapy | Coronary venous pacing lead | Indication General Cardiac pacing Against Bradycardia

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C3874606
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0205246
UMLS CUI [3,3]
C0199640
UMLS CUI [3,4]
C0521124
UMLS CUI [3,5]
C0428977
have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
Description

Neuromuscular Disease Preventing Walking Normal | orthopedic problem Preventing Walking Normal | Other medical condition Preventing Walking Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0027868
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0080331
UMLS CUI [1,4]
C0205307
UMLS CUI [2,1]
C0029354
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0080331
UMLS CUI [2,4]
C0205307
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0080331
UMLS CUI [3,4]
C0205307
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 180 days prior to enrollment
Description

Tachyarrhythmia Atrial Permanent | Tachyarrhythmia Atrial persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0080203
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205355
UMLS CUI [2,1]
C0080203
UMLS CUI [2,2]
C0018792
UMLS CUI [2,3]
C0205322
have a hypersensitivity to a 0.7 mg dose of dexamethasone acetate
Description

Hypersensitivity dexamethasone acetate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0057598
have surgically uncorrected primary valvular heart disease
Description

primary valvular heart disease uncorrected Surgical

Data type

boolean

Alias
UMLS CUI [1,1]
C2064629
UMLS CUI [1,2]
C4072785
UMLS CUI [1,3]
C0543467
currently requiring dialysis
Description

Dialysis procedure Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0686904
have chronic obstructive pulmonary disease (copd), defined as fev1/fvc < 60%
Description

Chronic Obstructive Airway Disease | Forced expired volume in one second/forced vital capacity ratio

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0429745
have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the 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
have 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
have a mechanical tricuspid prosthesis
Description

Tricuspid valve prosthesis, device

Data type

boolean

Alias
UMLS CUI [1]
C1322659
enrolled in any concurrent study, without 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
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Similar models

Eligibility Congestive Heart Failure NCT00158951

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication General CRT-D device
Item
meet the general indications for a crt-d device
boolean
C3146298 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C1736558 (UMLS CUI [1,3])
Heart failure Moderate | Heart failure Severe | New York Heart Association Classification | Heart failure Pharmacotherapy Optimal
Item
moderate or severe heart failure, defined as nyha class iii-iv despite optimal pharmacological heart failure therapy.
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1275491 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C0013216 (UMLS CUI [4,2])
C2698651 (UMLS CUI [4,3])
12 lead ECG | Sinus rhythm | QRS duration | P-R interval | P wave duration
Item
a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm, qrs duration ³ 150 ms, and pr interval £ 320 ms measured from any two leads, and a p-wave duration < 150 ms measured from lead v1
boolean
C0430456 (UMLS CUI [1])
C0232201 (UMLS CUI [2])
C0429025 (UMLS CUI [3])
C0429087 (UMLS CUI [4])
C0429021 (UMLS CUI [5])
Creatinine measurement, serum
Item
creatinine £ 2.5 mg/dl obtained no more than 14 days prior to enrollment
boolean
C0201976 (UMLS CUI [1])
Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning | Cardiac Catheterization
Item
left ventricular ejection fraction £ 35% [measured by echo, multiple gated acquisition (muga) scan, cardiac catheterization, etc.] no more than 14 days prior to enrollment
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0018795 (UMLS CUI [4])
Device implant Capability | Protocol Compliance
Item
willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
boolean
C0948629 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of more than 180 days, per physician discretion
boolean
C0023671 (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])
Item Group
C0680251 (UMLS CUI)
Right bundle branch block morphology | 12 lead ECG
Item
right bundle branch block morphology (per world health organization guidelines) on a 12-lead ecg obtained no more than 90 days prior to enrollment.
boolean
C0085615 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2])
Cardiac Resynchronization Therapy | Coronary venous pacing lead | Indication General Cardiac pacing Against Bradycardia
Item
have had previous cardiac resynchronization therapy, a previous coronary venous lead, or meet the general indications for antibradycardia pacing
boolean
C1167956 (UMLS CUI [1])
C3874606 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0205246 (UMLS CUI [3,2])
C0199640 (UMLS CUI [3,3])
C0521124 (UMLS CUI [3,4])
C0428977 (UMLS CUI [3,5])
Neuromuscular Disease Preventing Walking Normal | orthopedic problem Preventing Walking Normal | Other medical condition Preventing Walking Normal
Item
have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
boolean
C0027868 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,4])
C0029354 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0080331 (UMLS CUI [2,3])
C0205307 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0080331 (UMLS CUI [3,3])
C0205307 (UMLS CUI [3,4])
Tachyarrhythmia Atrial Permanent | Tachyarrhythmia Atrial persistent
Item
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 180 days prior to enrollment
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C0080203 (UMLS CUI [2,1])
C0018792 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])
Hypersensitivity dexamethasone acetate
Item
have a hypersensitivity to a 0.7 mg dose of dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
primary valvular heart disease uncorrected Surgical
Item
have surgically uncorrected primary valvular heart disease
boolean
C2064629 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Dialysis procedure Patient need for
Item
currently requiring dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease | Forced expired volume in one second/forced vital capacity ratio
Item
have chronic obstructive pulmonary disease (copd), defined as fev1/fvc < 60%
boolean
C0024117 (UMLS CUI [1])
C0429745 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the 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
have 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])
Tricuspid valve prosthesis, device
Item
have a mechanical tricuspid prosthesis
boolean
C1322659 (UMLS CUI [1])
Study Subject Participation Status Interferes with research results
Item
enrolled in any concurrent study, without 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])
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