Status:
UNKNOWN
First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension
Lead Sponsor:
Cibiem, Inc.
Conditions:
Hypertension,Essential
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maint...
Eligibility Criteria
Inclusion
- Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
- Mean daytime systolic ABPM ≥135 mmHg during screen-in period
- Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure
- No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
- Negative pregnancy test for women of child-bearing age
- Willingness and able to comply with follow-up requirements
- Signed informed consent
Exclusion
- Secondary causes of hypertension
- Calculated eGFR \<30mL/min/1.73m2
- History of repeated episodes of hypoglycemic unawareness
- Morbid obesity, defined as Body Mass Index \>40 kg/m2
- Severe obstructive sleep apnea (AHI \> 35/hr.)
- Pacemaker and/or implantable defibrillators
- History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
- History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
- History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting
Key Trial Info
Start Date :
December 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03314012
Start Date
December 11 2015
End Date
January 1 2020
Last Update
April 10 2018
Active Locations (7)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
3
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
4
Na Homolce Hospital
Prague, Czechia, 15030