ID

20832

Description

RAPID-RF: Remote Active Monitoring in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00334451

Link

https://clinicaltrials.gov/show/NCT00334451

Keywords

  1. 3/21/17 3/21/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

March 21, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Heart Failure NCT00334451

Eligibility Heart Failure NCT00334451

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet current indications for a guidant rf-enabled crt-d device (e.g. contak renewal 3 rf family of crt-d devices) which is compatible with the latitude communicator. indications include: nyha class iii, iv; ef of ≤ 35%; qrs duration of
Description

Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D) Radiofrequency ablation | New York Heart Association Classification | Ejection fraction | QRS complex duration

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1736558
UMLS CUI [1,3]
C0850292
UMLS CUI [2]
C1275491
UMLS CUI [3]
C2700378
UMLS CUI [4]
C0429025
≥ 120 ms; and optimized pharmacologic therapy
Description

Pharmacotherapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
patients who have an analog telephone line compatible with the latitude communicator. the latitude communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
Description

Access to telephone Compatible with Clinical Trial Component

Data type

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0449432
patients who receive the study components including the latitude communicator, weight scale, and blood pressure monitor
Description

Clinical Trial Components | Scale weight | Blood Pressure Monitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449432
UMLS CUI [2]
C3878937
UMLS CUI [3]
C1622509
patients who are willing and capable of providing informed consent prior to implant and willing to participate in the rapid-rf registry
Description

Informed Consent | Participation Registry Radiofrequency ablation Rapid

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0034975
UMLS CUI [2,3]
C0850292
UMLS CUI [2,4]
C0456962
patients who remain in the clinical care of a rapid-rf investigator at approved centers
Description

Patient care Clinical Investigator Radiofrequency ablation Rapid

Data type

boolean

Alias
UMLS CUI [1,1]
C0017313
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0850292
UMLS CUI [1,4]
C0456962
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are expected to receive a heart transplant during the course of the study
Description

Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
Description

Tricuspid valve prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C3839627
patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular icd)
Description

Cardiac Resynchronization Therapy Device | Biventricular Pacemaker | Implantable defibrillator biventricular

Data type

boolean

Alias
UMLS CUI [1]
C2936377
UMLS CUI [2]
C1719274
UMLS CUI [3,1]
C0162589
UMLS CUI [3,2]
C0699808
patients whose life expectancy is less than 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the rapid-rf registry. contact guidant's clinical application research study (cars) department to determine eligibility.
Description

Study Subject Participation Status Impact Therapeutic procedure | Study Subject Participation Status Impact Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0683954
patients who are younger than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients who are pregnant or plan to become pregnant during the study
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients who are unable or refuse to comply with the protocol requirements
Description

Protocol Compliance Unable | Protocol Compliance Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1705116

Similar models

Eligibility Heart Failure NCT00334451

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D) Radiofrequency ablation | New York Heart Association Classification | Ejection fraction | QRS complex duration
Item
patients who meet current indications for a guidant rf-enabled crt-d device (e.g. contak renewal 3 rf family of crt-d devices) which is compatible with the latitude communicator. indications include: nyha class iii, iv; ef of ≤ 35%; qrs duration of
boolean
C3146298 (UMLS CUI [1,1])
C1736558 (UMLS CUI [1,2])
C0850292 (UMLS CUI [1,3])
C1275491 (UMLS CUI [2])
C2700378 (UMLS CUI [3])
C0429025 (UMLS CUI [4])
Pharmacotherapy Optimal
Item
≥ 120 ms; and optimized pharmacologic therapy
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Access to telephone Compatible with Clinical Trial Component
Item
patients who have an analog telephone line compatible with the latitude communicator. the latitude communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
boolean
C1822200 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0449432 (UMLS CUI [1,4])
Clinical Trial Components | Scale weight | Blood Pressure Monitor
Item
patients who receive the study components including the latitude communicator, weight scale, and blood pressure monitor
boolean
C0008976 (UMLS CUI [1,1])
C0449432 (UMLS CUI [1,2])
C3878937 (UMLS CUI [2])
C1622509 (UMLS CUI [3])
Informed Consent | Participation Registry Radiofrequency ablation Rapid
Item
patients who are willing and capable of providing informed consent prior to implant and willing to participate in the rapid-rf registry
boolean
C0021430 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0034975 (UMLS CUI [2,2])
C0850292 (UMLS CUI [2,3])
C0456962 (UMLS CUI [2,4])
Patient care Clinical Investigator Radiofrequency ablation Rapid
Item
patients who remain in the clinical care of a rapid-rf investigator at approved centers
boolean
C0017313 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0850292 (UMLS CUI [1,3])
C0456962 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation Expected
Item
patients who are expected to receive a heart transplant during the course of the study
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Tricuspid valve prosthesis
Item
patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
boolean
C3839627 (UMLS CUI [1])
Cardiac Resynchronization Therapy Device | Biventricular Pacemaker | Implantable defibrillator biventricular
Item
patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular icd)
boolean
C2936377 (UMLS CUI [1])
C1719274 (UMLS CUI [2])
C0162589 (UMLS CUI [3,1])
C0699808 (UMLS CUI [3,2])
Life Expectancy
Item
patients whose life expectancy is less than 12 months
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status Impact Therapeutic procedure | Study Subject Participation Status Impact Research results
Item
patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the rapid-rf registry. contact guidant's clinical application research study (cars) department to determine eligibility.
boolean
C2348568 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Age
Item
patients who are younger than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
patients who are pregnant or plan to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Protocol Compliance Unable | Protocol Compliance Refused
Item
patients who are unable or refuse to comply with the protocol requirements
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial