ID

44400

Description

Dual Site Left Ventricular (LV) Pacing; ODM derived from: https://clinicaltrials.gov/show/NCT00944125

Link

https://clinicaltrials.gov/show/NCT00944125

Keywords

Versions (2)
  1. 1/9/18 1/9/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00944125

English

Eligibility Congestive Heart Failure NCT00944125

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
moderate or severe heart failure, defined as nyha class iii-iv despite optimal pharmacological heart failure therapy
Description

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

Data type

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]
C0013216
UMLS CUI [3,2]
C2698651
on heart failure medical regimen (beta blockers and ace-i or arb's) for at least one month before randomization
Description

Therapeutic procedure Heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0304516
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a qrs duration > 120 ms
Description

QRS duration 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
left ventricular ejection fraction (lvef) < 35% or equal
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
Description

Protocol Compliance | Insertion of therapeutic device | Participation Testing

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0184961
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C0039593
have a life expectancy of more than 180 days, per physician discretion
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
age 40 or above, ensuring of legal age to give informed consent specific to state and national law
Description

Age | Age Legal | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1301860
UMLS CUI [3]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have had previous cardiac resynchronization therapy or a previous coronary venous lead
Description

Cardiac Resynchronization Therapy | Coronary venous pacing lead

Data type

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C3874606
unable to perform a six-minute hall walk (6mhw) test
Description

6-minute walk test Performance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C1882330
UMLS CUI [1,3]
C1299582
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without chb or planned avj ablation prior to randomization
Description

Tachyarrhythmia atrial permanent | Congenital heart block Absent | Absence Atrioventricular junction Ablation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0080203
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205355
UMLS CUI [2,1]
C0149530
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0729580
UMLS CUI [3,3]
C0547070
UMLS CUI [3,4]
C1301732
have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no avj ablation will be exited.)
Description

Tachyarrhythmia atrial persistent | Absence Cardioversion Planned Successful

Data type

boolean

Alias
UMLS CUI [1,1]
C0080203
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205322
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013778
UMLS CUI [2,3]
C1301732
UMLS CUI [2,4]
C1272703
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
Description

Hypertrophic Obstructive Cardiomyopathy | Cardiomyopathy Infiltrating | Amyloidosis | Sarcoidosis

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2,1]
C0878544
UMLS CUI [2,2]
C0332448
UMLS CUI [3]
C0002726
UMLS CUI [4]
C0036202
have a mechanical tricuspid prosthesis
Description

Tricuspid valve prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C1322659
has severe aortic or mitral stenosis
Description

Aortic Valve Stenosis Severe | Mitral Valve Stenosis Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0026269
UMLS CUI [2,2]
C0205082
enrolled in any concurrent study 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
patients who are or suspect they may be pregnant or plan to become pregnant
Description

Pregnancy | Pregnancy Suspected | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0032992
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Similar models

Eligibility Congestive Heart Failure NCT00944125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | 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])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0013216 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
Therapeutic procedure Heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
on heart failure medical regimen (beta blockers and ace-i or arb's) for at least one month before randomization
boolean
C0087111 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0304516 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
QRS duration 12 lead ECG
Item
a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a qrs duration > 120 ms
boolean
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) < 35% or equal
boolean
C0428772 (UMLS CUI [1])
Protocol Compliance | Insertion of therapeutic device | Participation Testing
Item
willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
boolean
C0525058 (UMLS CUI [1])
C0184961 (UMLS CUI [2])
C0679823 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Life Expectancy
Item
have a life expectancy of more than 180 days, per physician discretion
boolean
C0023671 (UMLS CUI [1])
Age | Age Legal | Informed Consent
Item
age 40 or above, ensuring of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cardiac Resynchronization Therapy | Coronary venous pacing lead
Item
have had previous cardiac resynchronization therapy or a previous coronary venous lead
boolean
C1167956 (UMLS CUI [1])
C3874606 (UMLS CUI [2])
6-minute walk test Performance Unable
Item
unable to perform a six-minute hall walk (6mhw) test
boolean
C0430515 (UMLS CUI [1,1])
C1882330 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Tachyarrhythmia atrial permanent | Congenital heart block Absent | Absence Atrioventricular junction Ablation Planned
Item
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without chb or planned avj ablation prior to randomization
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C0149530 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0729580 (UMLS CUI [3,2])
C0547070 (UMLS CUI [3,3])
C1301732 (UMLS CUI [3,4])
Tachyarrhythmia atrial persistent | Absence Cardioversion Planned Successful
Item
have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no avj ablation will be exited.)
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C1272703 (UMLS CUI [2,4])
Hypertrophic Obstructive Cardiomyopathy | Cardiomyopathy Infiltrating | Amyloidosis | Sarcoidosis
Item
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
boolean
C0007194 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0002726 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
Tricuspid valve prosthesis
Item
have a mechanical tricuspid prosthesis
boolean
C1322659 (UMLS CUI [1])
Aortic Valve Stenosis Severe | Mitral Valve Stenosis Severe
Item
has severe aortic or mitral stenosis
boolean
C0003507 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0026269 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results
Item
enrolled in any concurrent study that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Pregnancy | Pregnancy Suspected | Pregnancy, Planned
Item
patients who are or suspect they may be pregnant or plan to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
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