ID

41027

Beschreibung

A Prospective, Single Arm, Multi-Center Clinical Study in Collaboration With the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD® System in Patients With Advanced Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02268942

Link

https://clinicaltrials.gov/show/NCT02268942

Stichworte

Versionen (1)
  1. 15.06.20 15.06.20 -
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See clinicaltrials.gov

Hochgeladen am

15. Juni 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Left Sided Heart Failure NCT02268942

Englisch

Eligibility Left Sided Heart Failure NCT02268942

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. must be ≥19 years of age at time of informed consent to participate in the intermacs®
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
registry.
Beschreibung

ID.2

Datentyp

boolean

2. subject receives a heartware® hvad (the device should be the subject's first vad implant).
Beschreibung

Ventricular Assist Device Placement Firstly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825193
UMLS CUI [1,2]
C1279901
3. subject signed an intermacs® informed consent if required by local irb policy.
Beschreibung

Informed Consent Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0205369
4. subject signed a heartware ®informed consent.
Beschreibung

Informed Consent Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0205369
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject is incarcerated (prisoner).
Beschreibung

Prisoner

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
2. subject did not sign the informed consent at sites where waiver of consent was not granted.
Beschreibung

Informed Consent Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
3. body surface area (bsa) < 1.2 m^2.
Beschreibung

Body Surface Area

Datentyp

boolean

Alias
UMLS CUI [1]
C0005902
4. prior cardiac transplant or cardiomyoplasty.
Beschreibung

Heart Transplantation | Cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0878544
5. subject is receiving a bivad.
Beschreibung

Implantation of biventricular assist device

Datentyp

boolean

Alias
UMLS CUI [1]
C0397131
6. subject is receiving the device as an rvad.
Beschreibung

Right Cardiac Ventricle Assist Device Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C3272255
7. subject data is generated from non- intermacs® centers.
Beschreibung

Patient data Clinic/Center Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2707520
UMLS CUI [1,2]
C1552416
UMLS CUI [1,3]
C0205394
8. pediatric subjects (< 19 years of age).
Beschreibung

Study Subject Pediatric | Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1521725
UMLS CUI [2]
C0001779
9. subjects who receive a temporary lvad
Beschreibung

Implantation of left ventricular assist device temporary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0397130
UMLS CUI [1,2]
C0205374
10. subjects whose device strategy is listed as "destination therapy" at the time of implant.
Beschreibung

Device strategy specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085842
UMLS CUI [1,2]
C0679199
UMLS CUI [1,3]
C0205369
11. severe right heart failure
Beschreibung

Right-Sided Heart Failure Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235527
UMLS CUI [1,2]
C0205082
12. aortic insufficiency or mechanical aortic valve.
Beschreibung

Aortic Valve Insufficiency | Mechanical Aortic Valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0003504
UMLS CUI [2]
C2825203
13. planned concomitant procedure (e.g.valve repair or replacement, cabg, septal defect repair).
Beschreibung

Planned procedure | Repair of heart valve | Valve replacement | Coronary Artery Bypass Surgery | Repair Procedures for Septal Defect

Datentyp

boolean

Alias
UMLS CUI [1]
C1320712
UMLS CUI [2]
C0190112
UMLS CUI [3]
C1410969
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0519387
14. known lv thrombus.
Beschreibung

Left ventricular thrombus

Datentyp

boolean

Alias
UMLS CUI [1]
C0587044
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Ähnliche Modelle

Eligibility Left Sided Heart Failure NCT02268942

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. must be ≥19 years of age at time of informed consent to participate in the intermacs®
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
registry.
boolean
Ventricular Assist Device Placement Firstly
Item
2. subject receives a heartware® hvad (the device should be the subject's first vad implant).
boolean
C2825193 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
Informed Consent Specified
Item
3. subject signed an intermacs® informed consent if required by local irb policy.
boolean
C0021430 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Informed Consent Specified
Item
4. subject signed a heartware ®informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prisoner
Item
1. subject is incarcerated (prisoner).
boolean
C0033167 (UMLS CUI [1])
Informed Consent Absent
Item
2. subject did not sign the informed consent at sites where waiver of consent was not granted.
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Body Surface Area
Item
3. body surface area (bsa) < 1.2 m^2.
boolean
C0005902 (UMLS CUI [1])
Heart Transplantation | Cardiomyopathy
Item
4. prior cardiac transplant or cardiomyoplasty.
boolean
C0018823 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
Implantation of biventricular assist device
Item
5. subject is receiving a bivad.
boolean
C0397131 (UMLS CUI [1])
Right Cardiac Ventricle Assist Device Procedure
Item
6. subject is receiving the device as an rvad.
boolean
C3272255 (UMLS CUI [1])
Patient data Clinic/Center Other
Item
7. subject data is generated from non- intermacs® centers.
boolean
C2707520 (UMLS CUI [1,1])
C1552416 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Study Subject Pediatric | Age
Item
8. pediatric subjects (< 19 years of age).
boolean
C0681850 (UMLS CUI [1,1])
C1521725 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Implantation of left ventricular assist device temporary
Item
9. subjects who receive a temporary lvad
boolean
C0397130 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
Device strategy specified
Item
10. subjects whose device strategy is listed as "destination therapy" at the time of implant.
boolean
C0085842 (UMLS CUI [1,1])
C0679199 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Right-Sided Heart Failure Severe
Item
11. severe right heart failure
boolean
C0235527 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Aortic Valve Insufficiency | Mechanical Aortic Valve
Item
12. aortic insufficiency or mechanical aortic valve.
boolean
C0003504 (UMLS CUI [1])
C2825203 (UMLS CUI [2])
Planned procedure | Repair of heart valve | Valve replacement | Coronary Artery Bypass Surgery | Repair Procedures for Septal Defect
Item
13. planned concomitant procedure (e.g.valve repair or replacement, cabg, septal defect repair).
boolean
C1320712 (UMLS CUI [1])
C0190112 (UMLS CUI [2])
C1410969 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0519387 (UMLS CUI [5])
Left ventricular thrombus
Item
14. known lv thrombus.
boolean
C0587044 (UMLS CUI [1])
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