Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001280594
Ethics application status
Approved
Date submitted
18/11/2015
Date registered
24/11/2015
Date last updated
22/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
First-in-human study evaluating a novel catheter device in subjects with treatment-resistant hypertension: a safety and feasibility study.
Scientific title
First-in-human study for ultrasound based endovascular carotid body ablation in subjects with treatment-resistant hypertension: a safety and feasibility study.
Secondary ID [1] 287914 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
TREATMENT-RESISTANT HYPERTENSION 296796 0
Condition category
Condition code
Cardiovascular 297026 297026 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cibiem Transvenous Ultrasound System (CTUS) is a catheter based device delivering ultrasound energy to ablate the carotid body. The procedure is done via a percutaneous Insertion of the CTUS and advancement though the femoral vein to the jugular vein in subjects with difficult to control hypertension. Duration of the procedure is expected to range between 60 to 90 minutes. Procedure performed under fluoroscopic and ultrasound imaging guidance.
Intervention code [1] 293271 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296624 0
Safety assessed as the combined rate of major adverse events defined as All-causes of death, Hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications, Any device or procedure-related serious adverse event
Timepoint [1] 296624 0
Clinical assessment one month following the treatment procedure
Primary outcome [2] 296625 0
Composite assessment of mean reduction in 24-hour ambulatory systolic and diastolic blood pressure (ABP) at six (6) months post-treatment vs. subject baseline measured using digital automatic sphygmomanometer
Timepoint [2] 296625 0
24-hour ambulatory systolic and diastolic blood pressure assessment six (6) month following the treatment procedure
Secondary outcome [1] 318945 0
The composite rate of Major Adverse Events defined as
All causes of death related or unrelated to the procedure/ treatment approach
Hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications confirmed after careful blood pressure determination and verification of medical treatment compliance.
Timepoint [1] 318945 0
Clinical assessment at 6, 12, 18 and 24 months post-procedure

Eligibility
Key inclusion criteria
Mean daytime systolic ABPM equal or greater than 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, unless diuretic intolerance is documented), with no medication changes expected for at least six (6) months post-procedure
Willingness and able to comply with follow-up requirements
Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Secondary causes of hypertension
Calculated eGFR smaller than 30mL/min/1.73m2
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
Life expectancy of less than 12 months due to other disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/12/2015
Actual
10/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 292400 0
Commercial sector/Industry
Name [1] 292400 0
Cibiem Australia Pty Ltd
Country [1] 292400 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cibiem Australia Pty Ltd
Address
10/120 Saunders St, Sydney 2009 NSW
Country
Australia
Secondary sponsor category [1] 291083 0
None
Name [1] 291083 0
Address [1] 291083 0
Country [1] 291083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293868 0
ROYAL PERTH HOSPITAL HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 293868 0
Level 5 Colonial House, Royal Perth Hospital, GPO Box X2213 Perth WA 6001
Ethics committee country [1] 293868 0
Australia
Date submitted for ethics approval [1] 293868 0
03/07/2015
Approval date [1] 293868 0
24/08/2015
Ethics approval number [1] 293868 0
15-089

Summary
Brief summary
The objective of this First-in-Human (FIH) evaluation is to assess the safety and effectiveness of the Cibiem Transvenous Ultrasound System (CTUS) for percutaneous unilateral carotid body ablation in subjects with difficult to control hypertension.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61590 0
Prof Markus Schlaich
Address 61590 0
School of Medicine and Pharmacology Royal Perth Hospital Unit
Faculty of Medicine, Dentistry & Health Sciences, The University of Western Australia
Level 3, MRF Building, Rear 50 Murray St, PERTH WA 6000, MDBP: M570
Country 61590 0
Australia
Phone 61590 0
+61 8 9224 0382
Fax 61590 0
+61 8 9224 0374
Email 61590 0
markus.schlaich@uwa.edu.au
Contact person for public queries
Name 61591 0
Ms Sara Tomkoria
Address 61591 0
Cibiem, Inc
5150 El Camino Real
Suite E30
Los Altos, CA 94022
Country 61591 0
United States of America
Phone 61591 0
+1 4084708872
Fax 61591 0
Email 61591 0
stomkoria@cibiem.com
Contact person for scientific queries
Name 61592 0
Prof Markus Schlaich
Address 61592 0
School of Medicine and Pharmacology - Royal Perth Hospital Unit
Faculty of Medicine, Dentistry & Health Sciences The University of Western Australia
Level 3, MRF Building, Rear 50 Murray St, PERTH WA 6000 MDBP: M570
Country 61592 0
Australia
Phone 61592 0
+61 8 9224 0382
Fax 61592 0
+61 8 9224 0374
Email 61592 0
markus.schlaich@uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.