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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03314012




Registration number
NCT03314012
Ethics application status
Date submitted
15/10/2017
Date registered
19/10/2017
Date last updated
10/04/2018

Titles & IDs
Public title
First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension
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] 0 0
CL1008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension,Essential 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Catheter-Based Carotid Body Ablation

Experimental: Catheter-Based Carotid Body Ablation - All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS).


Treatment: Devices: Catheter-Based Carotid Body Ablation
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 through the femoral vein to the jugular vein in subjects with difficult to control hypertension. The procedure duration is expected to range between 60 to 90 minutes and is performed under fluoroscopic and ultrasound image guidance.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as assessed by incidence of major adverse events
Timepoint [1] 0 0
From procedure to one month post-procedure
Primary outcome [2] 0 0
Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
Timepoint [2] 0 0
Baseline versus six months post-procedure
Secondary outcome [1] 0 0
Composite rate of major adverse events
Timepoint [1] 0 0
At 6, 12, 18, and 24 months post-procedure
Secondary outcome [2] 0 0
Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure
Timepoint [2] 0 0
Baseline versus 3, 6, 12, 18, and 24 months
Secondary outcome [3] 0 0
Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure
Timepoint [3] 0 0
At 6, 12, 18, and 24 months
Secondary outcome [4] 0 0
Ventricular morphometric improvements from cardiac MRI measurements
Timepoint [4] 0 0
Screening versus 12 and 24 months

Eligibility
Key inclusion criteria
- 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
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 <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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague
Country [2] 0 0
Germany
State/province [2] 0 0
Bad Krozingen
Country [3] 0 0
Germany
State/province [3] 0 0
Frankfurt
Country [4] 0 0
Germany
State/province [4] 0 0
Homburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cibiem, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 maintenance of hypertension. Hypertension is a major cardiovascular risk
factor and is associated with coronary artery disease, stroke, chronic kidney disease, and
heart failure.

The objective of this study is to assess the effectiveness and safety of a catheter-based
system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant
hypertension and to confirm sustainability of the treatment benefits long-term as seen
following surgical CB removal.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03314012
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich, Professor
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03314012