ID

44748

Description

RENABLATE-II Feasibility - 157; ODM derived from: https://clinicaltrials.gov/show/NCT02095691

Link

https://clinicaltrials.gov/show/NCT02095691

Keywords

Versions (1)
  1. 11/10/21 11/10/21 -
Copyright Holder

Biosense Webster, Inc.

Uploaded on

November 10, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Renal Denervation NCT02095691

English

Eligibility Renal Denervation NCT02095691

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject has a systolic blood pressure ≥ 140 mmhg based on an average of 3 office blood pressure readings measured according to the bp guidelines.
Description

subject has a systolic blood pressure ≥ 140 mmhg based on an average of 3 office blood pressure readings measured according to the bp guidelines

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C0031834
UMLS CUI [1,5]
C0750480
UMLS CUI [1,6]
C1510992
2. subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
Description

subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0237125
UMLS CUI [1,4]
C0205360
UMLS CUI [1,5]
C1321605
UMLS CUI [1,6]
C0012798
UMLS CUI [1,7]
C0178602
UMLS CUI [1,8]
C2698651
3. subject is > 18 and < 85 years of age.
Description

subject is > 18 and < 85 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.
Description

subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0086035
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0199171
UMLS CUI [2,2]
C2347804
UMLS CUI [2,3]
C0680240
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI [1]
C0680251
1. a secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h abpm at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, adult polycystic kidney disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, cushing's syndrome, conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
Description

a secondary cause of hypertension, e.g.

Data type

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0262534
UMLS CUI [1,3]
C1282173
UMLS CUI [1,4]
C1719312
UMLS CUI [1,5]
C0031511
UMLS CUI [1,6]
C0035067
UMLS CUI [1,7]
C0020538
UMLS CUI [1,8]
C0458082
UMLS CUI [1,9]
C0022680
UMLS CUI [1,10]
C0007134
UMLS CUI [1,11]
C0034186
UMLS CUI [1,12]
C0017658
UMLS CUI [1,13]
C0003492
UMLS CUI [1,14]
C0001206
UMLS CUI [1,15]
C0010481
UMLS CUI [1,16]
C1384514
UMLS CUI [1,17]
C0031036
UMLS CUI [1,18]
C0205373
UMLS CUI [1,19]
C0036429
UMLS CUI [1,20]
C0022658
UMLS CUI [1,21]
C4277702
UMLS CUI [1,22]
C0520679
2. subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
Description

subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s)

Data type

boolean

Alias
UMLS CUI [1,1]
C0015801
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C1512714
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C2346570
3. subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.
Description

subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0035065
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1444754
UMLS CUI [1,4]
C1522609
UMLS CUI [2,1]
C0035065
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C1522609
4. subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting , renal denervation or surgery.
Description

subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting , renal denervation or surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035065
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C0002996
UMLS CUI [1,5]
C0038257
UMLS CUI [1,6]
C3544270
UMLS CUI [1,7]
C0543467
5. subject has an estimated glomerular filtration rate (egfr) of < 45ml/min/1.73m2, using the mdrd formula.
Description

subject has an estimated glomerular filtration rate (egfr) of < 45ml/min/1.73m2, using the mdrd formula

Data type

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C1522609
UMLS CUI [1,3]
C3839656
6. subject has type 1 diabetes mellitus.
Description

subject has type 1 diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
7. subject has history of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.
Description

subject has history of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0038454
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0004153
UMLS CUI [4,2]
C1301725
UMLS CUI [5,1]
C0040053
UMLS CUI [5,2]
C0442123
UMLS CUI [5,3]
C1301725
UMLS CUI [6,1]
C0332461
UMLS CUI [6,2]
C0443343
UMLS CUI [6,3]
C1301725
8. subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
Description

subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C0005823
UMLS CUI [1,5]
C0441610
UMLS CUI [1,6]
C0035647
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Similar models

Eligibility Renal Denervation NCT02095691

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
subject has a systolic blood pressure ≥ 140 mmhg based on an average of 3 office blood pressure readings measured according to the bp guidelines
Item
1. subject has a systolic blood pressure ≥ 140 mmhg based on an average of 3 office blood pressure readings measured according to the bp guidelines.
boolean
C0871470 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0031834 (UMLS CUI [1,4])
C0750480 (UMLS CUI [1,5])
C1510992 (UMLS CUI [1,6])
subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months
Item
2. subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
boolean
C0003364 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0237125 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C1321605 (UMLS CUI [1,5])
C0012798 (UMLS CUI [1,6])
C0178602 (UMLS CUI [1,7])
C2698651 (UMLS CUI [1,8])
subject is > 18 and < 85 years of age
Item
3. subject is > 18 and < 85 years of age.
boolean
C0001779 (UMLS CUI [1])
subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study
Item
4. subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.
boolean
C0021430 (UMLS CUI [1,1])
C0086035 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0199171 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0680240 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI [1])
a secondary cause of hypertension, e.g.
Item
1. a secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h abpm at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, adult polycystic kidney disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, cushing's syndrome, conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
boolean
C0155616 (UMLS CUI [1,1])
C0262534 (UMLS CUI [1,2])
C1282173 (UMLS CUI [1,3])
C1719312 (UMLS CUI [1,4])
C0031511 (UMLS CUI [1,5])
C0035067 (UMLS CUI [1,6])
C0020538 (UMLS CUI [1,7])
C0458082 (UMLS CUI [1,8])
C0022680 (UMLS CUI [1,9])
C0007134 (UMLS CUI [1,10])
C0034186 (UMLS CUI [1,11])
C0017658 (UMLS CUI [1,12])
C0003492 (UMLS CUI [1,13])
C0001206 (UMLS CUI [1,14])
C0010481 (UMLS CUI [1,15])
C1384514 (UMLS CUI [1,16])
C0031036 (UMLS CUI [1,17])
C0205373 (UMLS CUI [1,18])
C0036429 (UMLS CUI [1,19])
C0022658 (UMLS CUI [1,20])
C4277702 (UMLS CUI [1,21])
C0520679 (UMLS CUI [1,22])
subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s)
Item
2. subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
boolean
C0015801 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C2346570 (UMLS CUI [1,5])
subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter
Item
3. subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.
boolean
C0035065 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,4])
C0035065 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C1522609 (UMLS CUI [2,4])
subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting , renal denervation or surgery
Item
4. subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting , renal denervation or surgery.
boolean
C0262926 (UMLS CUI [1,1])
C0035065 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0002996 (UMLS CUI [1,4])
C0038257 (UMLS CUI [1,5])
C3544270 (UMLS CUI [1,6])
C0543467 (UMLS CUI [1,7])
subject has an estimated glomerular filtration rate (egfr) of < 45ml/min/1.73m2, using the mdrd formula
Item
5. subject has an estimated glomerular filtration rate (egfr) of < 45ml/min/1.73m2, using the mdrd formula.
boolean
C3811844 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C3839656 (UMLS CUI [1,3])
subject has type 1 diabetes mellitus
Item
6. subject has type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
subject has history of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques
Item
7. subject has history of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.
boolean
C0027051 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0004153 (UMLS CUI [4,1])
C1301725 (UMLS CUI [4,2])
C0040053 (UMLS CUI [5,1])
C0442123 (UMLS CUI [5,2])
C1301725 (UMLS CUI [5,3])
C0332461 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C1301725 (UMLS CUI [6,3])
subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
Item
8. subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
C0441610 (UMLS CUI [1,5])
C0035647 (UMLS CUI [1,6])
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