ID

17415

Description

Safety and Efficacy Study of RENEWAL 4 AVT; ODM derived from: https://clinicaltrials.gov/show/NCT00180336

Link

https://clinicaltrials.gov/show/NCT00180336

Keywords

Versions (1)
  1. 9/12/16 9/12/16 -
Uploaded on

September 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00180336

English

Eligibility Heart Failure NCT00180336

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
indications for the device
Description

Indication Medical Device

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0025080
availability for follow-up at an approved field following center, at the protocol defined intervals
Description

Study Protocol Interval Follow-up Availability

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1272706
UMLS CUI [1,3]
C3274571
UMLS CUI [1,4]
C0470187
willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
Description

Device implant Willing | Testing participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0948629
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0039593
UMLS CUI [2,2]
C0679823
prescribed to stable optimal pharmacologic therapy for hf
Description

Heart failure Pharmacotherapy Optimal Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C2698651
UMLS CUI [1,4]
C0205360
age 18 or above, or of legal age to give informed consent specific to national law
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion.
Description

Atrial Fibrillation Episode Quantity Evidence | Atrial Tachyarrhythmia Episode Quantity Evidence | Anticoagulation Therapy Recommended

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332120
UMLS CUI [2,1]
C0080203
UMLS CUI [2,2]
C0018792
UMLS CUI [2,3]
C0332189
UMLS CUI [2,4]
C1265611
UMLS CUI [2,5]
C0332120
UMLS CUI [3,1]
C0003281
UMLS CUI [3,2]
C0034866
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
right bundle branch block morphology
Description

Right bundle branch block Morphology

Data type

boolean

Alias
UMLS CUI [1,1]
C0085615
UMLS CUI [1,2]
C0332437
life expectancy of less than six months due to other medical conditions
Description

Life Expectancy Due to Other medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
expectation of a heart transplant during the period of the study
Description

Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
Description

Mechanical heart valve prosthesis Tricuspid valve

Data type

boolean

Alias
UMLS CUI [1,1]
C3873910
UMLS CUI [1,2]
C0040960
have a preexisting unipolar pacemaker that will not be explanted/abandoned
Description

Artificial cardiac pacemaker Unipolar Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0443340
UMLS CUI [1,3]
C2347662
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
Description

Atrial Tachyarrhythmia Permanent

Data type

boolean

Alias
UMLS CUI [1,1]
C0080203
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205355
have a known hypersensitivity to dexamethasone acetate
Description

Hypersensitivity dexamethasone acetate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0057598
enrolled in any other study, including drug investigation
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
women that are pregnant or planning to become pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
a cerebral vascular event/ transient ischemic attack within 12 months of implantation
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
during the four weeks prior to implantation, a patient experiences an episode of af >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (inr >= 2.0) for the 4 weeks prior to enrollment
Description

Atrial Fibrillation Episode Duration | Anticoagulation Therapy Inadequate | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0205412
UMLS CUI [3]
C0525032
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Similar models

Eligibility Heart Failure NCT00180336

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Medical Device
Item
indications for the device
boolean
C3146298 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
Study Protocol Interval Follow-up Availability
Item
availability for follow-up at an approved field following center, at the protocol defined intervals
boolean
C2348563 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
Device implant Willing | Testing participation
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])
C0600109 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
Heart failure Pharmacotherapy Optimal Stable
Item
prescribed to stable optimal pharmacologic therapy for hf
boolean
C0018801 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Age | Informed Consent
Item
age 18 or above, or of legal age to give informed consent specific to national law
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Atrial Fibrillation Episode Quantity Evidence | Atrial Tachyarrhythmia Episode Quantity Evidence | Anticoagulation Therapy Recommended
Item
able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion.
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C0080203 (UMLS CUI [2,1])
C0018792 (UMLS CUI [2,2])
C0332189 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0332120 (UMLS CUI [2,5])
C0003281 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Right bundle branch block Morphology
Item
right bundle branch block morphology
boolean
C0085615 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
Life Expectancy Due to Other medical condition
Item
life expectancy of less than six months due to other medical conditions
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Heart Transplantation Expected
Item
expectation of a heart transplant during the period of the study
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Mechanical heart valve prosthesis Tricuspid valve
Item
patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
boolean
C3873910 (UMLS CUI [1,1])
C0040960 (UMLS CUI [1,2])
Artificial cardiac pacemaker Unipolar Pre-existing
Item
have a preexisting unipolar pacemaker that will not be explanted/abandoned
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
Atrial Tachyarrhythmia Permanent
Item
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
Hypersensitivity dexamethasone acetate
Item
have a known hypersensitivity to dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
enrolled in any other study, including drug investigation
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
women that are pregnant or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
a cerebral vascular event/ transient ischemic attack within 12 months of implantation
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Atrial Fibrillation Episode Duration | Anticoagulation Therapy Inadequate | International Normalized Ratio
Item
during the four weeks prior to implantation, a patient experiences an episode of af >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (inr >= 2.0) for the 4 weeks prior to enrollment
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0003281 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0525032 (UMLS CUI [3])
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