ID

39519

Description

A Multinational Trial To Evaluate The Parachute Implant System; ODM derived from: https://clinicaltrials.gov/show/NCT01286116

Lien

https://clinicaltrials.gov/show/NCT01286116

Mots-clés

Versions (1)
  1. 22/01/2020 22/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 janvier 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01286116

Anglais

Eligibility Heart Failure NCT01286116

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
candidates for this study must meet all of the following inclusion criteria:
Description

Inclusion criteria All Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
Description

Akinesia Due to MYOCARDIAL INFARCTION ANTEROAPICAL | Dyskinesis Due to MYOCARDIAL INFARCTION ANTEROAPICAL

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085623
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0746714
UMLS CUI [2,1]
C0013384
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0746714
2. subject is not hospitalized at time of enrollment.
Description

Hospitalization Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0332197
3. diagnosis of heart failure for a minimum of 6 months prior to enrollment
Description

Heart failure Disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0872146
4. nyha class at time of enrollment, either:
Description

New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1]
C1275491
nyha class iii or ambulatory iv - if predominant during the 3-month period prior to enrollment
Description

New York Heart Association Classification | New York Heart Association Classification Ambulatory

Type de données

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C1275491
UMLS CUI [2,2]
C1561561
nyha class ii - if diagnosed with nyha class iii or iv during 3-month period prior to enrollment
Description

New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1]
C1275491
5. lvef >15% and ≤ 40% as measured by echocardiography.
Description

Left ventricular ejection fraction Echocardiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
6. post lv mi structural heart dysfunction represented by lv wall motion abnormality (wma) by echocardiography.
Description

Status post Left ventricle Myocardial Infarction | Heart dysfunction structural | Left ventricular wall motion abnormality Echocardiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0225897
UMLS CUI [1,3]
C0027051
UMLS CUI [2,1]
C0340515
UMLS CUI [2,2]
C0678594
UMLS CUI [3,1]
C1997551
UMLS CUI [3,2]
C0013516
7. eligible for cardiac surgery
Description

Eligibility Cardiac Surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0018821
8. between 18 and 79 years of age (inclusive)
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
9. receiving appropriate medical treatment for heart failure according to the acc/aha 2009 guideline update for the diagnosis and management of chronic heart failure in the adult during the three months prior to enrollment
Description

Therapy Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0018801
10. female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
Description

Childbearing Potential Pregnancy test negative | Planned Pregnancy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C0032992
UMLS CUI [2,2]
C0332197
11. provide written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
12. agree to the protocol-required follow-up
Description

Agreement Clinical Study Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
candidates will be excluded from the study if any of the following conditions apply:
Description

Criteria Any Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. untreated clinically significant coronary artery disease requiring intervention.
Description

Coronary Artery Disease Untreated | Requirement Intervention

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0184661
2. acute mi (see mi definition) within 60 days of enrollment or patients with suspected evolving mi at time of enrollment
Description

Myocardial Infarction | Myocardial Infarction Suspected

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0750491
3. cardiogenic shock within 72 hours of enrollment
Description

Shock, Cardiogenic

Type de données

boolean

Alias
UMLS CUI [1]
C0036980
4. revascularization procedure (pci or cabg) within 60 days of enrollment
Description

Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0581603
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0010055
5. patient has received a pacemaker, icd, or crt device within 60 days of enrollment
Description

Artificial cardiac pacemaker | ICD | Implantation of CRT-D

Type de données

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C1135480
6. moderate aortic stenosis and regurgitation (aortic or mitral) >2+.
Description

Aortic Valve Stenosis Moderate | Aortic Valve Insufficiency Moderate | Mitral Valve Insufficiency Moderate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003507
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0003504
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0026266
UMLS CUI [3,2]
C0205081
7. history of aborted sudden cardiac death, if patient has not received an icd and has potentially lethal ventricular arrhythmia, vt or vf
Description

Sudden Cardiac Death aborted | Implantable defibrillator Absent | Ventricular arrhythmia Lethal | Ventricular Tachycardia Lethal | Ventricular Fibrillation Lethal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085298
UMLS CUI [1,2]
C1609614
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0085612
UMLS CUI [3,2]
C3151529
UMLS CUI [4,1]
C0042514
UMLS CUI [4,2]
C3151529
UMLS CUI [5,1]
C0042510
UMLS CUI [5,2]
C3151529
8. a known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.
Description

Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Warfarin allergy | Medical contraindication Warfarin | Hypersensitivity Nitinol | Medical contraindication Nitinol | Contrast media allergy

Type de données

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0004057
UMLS CUI [3]
C0571776
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0019134
UMLS CUI [5]
C0571785
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0043031
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0068790
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0068790
UMLS CUI [9]
C0570562
9. aortic valve replacement or repair
Description

Replacement of aortic valve | Aortic Valve Repair

Type de données

boolean

Alias
UMLS CUI [1]
C0003506
UMLS CUI [2]
C0869750
10. blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
Description

Hematological Disease | Bleeding tendency | Blood Coagulation Disorders | Thrombophilia

Type de données

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0005779
UMLS CUI [4]
C0398623
11. active peptic ulcer or gi bleeding within the past 3 months
Description

Peptic Ulcer | Gastrointestinal Hemorrhage

Type de données

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
12. patient has suffered a cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months
Description

Cerebrovascular accident | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
13. history of kawasaki's disease
Description

Kawasaki's disease

Type de données

boolean

Alias
UMLS CUI [1]
C0026691
14. patient has received a heart, lung, liver and/or kidney transplant
Description

Heart Transplantation | Lung Transplantation | Transplantation of liver | Kidney Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0024128
UMLS CUI [3]
C0023911
UMLS CUI [4]
C0022671
15. patient on dialysis or expected to require hemodialysis within 12 months
Description

Dialysis | Requirement Hemodialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0019004
16. patient has chronic liver disease
Description

Chronic liver disease

Type de données

boolean

Alias
UMLS CUI [1]
C0341439
17. impaired renal function that places patient at risk of contrast induced renal failure
Description

Renal Insufficiency | At risk Kidney Failure Contrast Induced

Type de données

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0035078
UMLS CUI [2,3]
C0009924
UMLS CUI [2,4]
C0205263
18. ongoing sepsis, including active endocarditis.
Description

Sepsis | Endocarditis

Type de données

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2]
C0014118
19. co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)
Description

Comorbidity Associated with Life Expectancy | Factor Echocardiography Difficult | Factor Clinical Study Follow-up Difficult | Patient address Permanent Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023671
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0013516
UMLS CUI [2,3]
C0332218
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0332218
UMLS CUI [4,1]
C0421449
UMLS CUI [4,2]
C0205355
UMLS CUI [4,3]
C0332268
20. patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete
Description

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Follow-up Incomplete

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C0205257
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Similar models

Eligibility Heart Failure NCT01286116

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria All Fulfill
Item
candidates for this study must meet all of the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Akinesia Due to MYOCARDIAL INFARCTION ANTEROAPICAL | Dyskinesis Due to MYOCARDIAL INFARCTION ANTEROAPICAL
Item
1. akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
boolean
C0085623 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0746714 (UMLS CUI [1,3])
C0013384 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0746714 (UMLS CUI [2,3])
Hospitalization Absent
Item
2. subject is not hospitalized at time of enrollment.
boolean
C0019993 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Heart failure Disease length
Item
3. diagnosis of heart failure for a minimum of 6 months prior to enrollment
boolean
C0018801 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
New York Heart Association Classification
Item
4. nyha class at time of enrollment, either:
boolean
C1275491 (UMLS CUI [1])
New York Heart Association Classification | New York Heart Association Classification Ambulatory
Item
nyha class iii or ambulatory iv - if predominant during the 3-month period prior to enrollment
boolean
C1275491 (UMLS CUI [1])
C1275491 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])
New York Heart Association Classification
Item
nyha class ii - if diagnosed with nyha class iii or iv during 3-month period prior to enrollment
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography
Item
5. lvef >15% and ≤ 40% as measured by echocardiography.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Status post Left ventricle Myocardial Infarction | Heart dysfunction structural | Left ventricular wall motion abnormality Echocardiography
Item
6. post lv mi structural heart dysfunction represented by lv wall motion abnormality (wma) by echocardiography.
boolean
C0231290 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0340515 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
C1997551 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
Eligibility Cardiac Surgery
Item
7. eligible for cardiac surgery
boolean
C1548635 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
Age
Item
8. between 18 and 79 years of age (inclusive)
boolean
C0001779 (UMLS CUI [1])
Therapy Heart failure
Item
9. receiving appropriate medical treatment for heart failure according to the acc/aha 2009 guideline update for the diagnosis and management of chronic heart failure in the adult during the three months prior to enrollment
boolean
C0087111 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative | Planned Pregnancy Absent
Item
10. female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0032992 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent
Item
11. provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Agreement Clinical Study Follow-up
Item
12. agree to the protocol-required follow-up
boolean
C0680240 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Any Fulfill
Item
candidates will be excluded from the study if any of the following conditions apply:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Coronary Artery Disease Untreated | Requirement Intervention
Item
1. untreated clinically significant coronary artery disease requiring intervention.
boolean
C1956346 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
Myocardial Infarction | Myocardial Infarction Suspected
Item
2. acute mi (see mi definition) within 60 days of enrollment or patients with suspected evolving mi at time of enrollment
boolean
C0027051 (UMLS CUI [1])
C0027051 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Shock, Cardiogenic
Item
3. cardiogenic shock within 72 hours of enrollment
boolean
C0036980 (UMLS CUI [1])
Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
4. revascularization procedure (pci or cabg) within 60 days of enrollment
boolean
C0581603 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Artificial cardiac pacemaker | ICD | Implantation of CRT-D
Item
5. patient has received a pacemaker, icd, or crt device within 60 days of enrollment
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C1135480 (UMLS CUI [3])
Aortic Valve Stenosis Moderate | Aortic Valve Insufficiency Moderate | Mitral Valve Insufficiency Moderate
Item
6. moderate aortic stenosis and regurgitation (aortic or mitral) >2+.
boolean
C0003507 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003504 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0026266 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Sudden Cardiac Death aborted | Implantable defibrillator Absent | Ventricular arrhythmia Lethal | Ventricular Tachycardia Lethal | Ventricular Fibrillation Lethal
Item
7. history of aborted sudden cardiac death, if patient has not received an icd and has potentially lethal ventricular arrhythmia, vt or vf
boolean
C0085298 (UMLS CUI [1,1])
C1609614 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0085612 (UMLS CUI [3,1])
C3151529 (UMLS CUI [3,2])
C0042514 (UMLS CUI [4,1])
C3151529 (UMLS CUI [4,2])
C0042510 (UMLS CUI [5,1])
C3151529 (UMLS CUI [5,2])
Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Warfarin allergy | Medical contraindication Warfarin | Hypersensitivity Nitinol | Medical contraindication Nitinol | Contrast media allergy
Item
8. a known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.
boolean
C0004058 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0571776 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C0571785 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0043031 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0068790 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0068790 (UMLS CUI [8,2])
C0570562 (UMLS CUI [9])
Replacement of aortic valve | Aortic Valve Repair
Item
9. aortic valve replacement or repair
boolean
C0003506 (UMLS CUI [1])
C0869750 (UMLS CUI [2])
Hematological Disease | Bleeding tendency | Blood Coagulation Disorders | Thrombophilia
Item
10. blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
boolean
C0018939 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
C0398623 (UMLS CUI [4])
Peptic Ulcer | Gastrointestinal Hemorrhage
Item
11. active peptic ulcer or gi bleeding within the past 3 months
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
12. patient has suffered a cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Kawasaki's disease
Item
13. history of kawasaki's disease
boolean
C0026691 (UMLS CUI [1])
Heart Transplantation | Lung Transplantation | Transplantation of liver | Kidney Transplantation
Item
14. patient has received a heart, lung, liver and/or kidney transplant
boolean
C0018823 (UMLS CUI [1])
C0024128 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0022671 (UMLS CUI [4])
Dialysis | Requirement Hemodialysis
Item
15. patient on dialysis or expected to require hemodialysis within 12 months
boolean
C0011946 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0019004 (UMLS CUI [2,2])
Chronic liver disease
Item
16. patient has chronic liver disease
boolean
C0341439 (UMLS CUI [1])
Renal Insufficiency | At risk Kidney Failure Contrast Induced
Item
17. impaired renal function that places patient at risk of contrast induced renal failure
boolean
C1565489 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0035078 (UMLS CUI [2,2])
C0009924 (UMLS CUI [2,3])
C0205263 (UMLS CUI [2,4])
Sepsis | Endocarditis
Item
18. ongoing sepsis, including active endocarditis.
boolean
C0243026 (UMLS CUI [1])
C0014118 (UMLS CUI [2])
Comorbidity Associated with Life Expectancy | Factor Echocardiography Difficult | Factor Clinical Study Follow-up Difficult | Patient address Permanent Lacking
Item
19. co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)
boolean
C0009488 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C0421449 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Follow-up Incomplete
Item
20. patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C3274571 (UMLS CUI [4,1])
C0205257 (UMLS CUI [4,2])
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