Hypertension,EssentialNCT03314012
First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension
A study testing Catheter-Based Carotid Body Ablation in people with Hypertension,Essential, run by Cibiem, Inc. at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Catheter-Based Carotid Body Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 11 Dec 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Royal Perth Hospital
Perth, Western Australia, 6000
Germany3 sites
Clinic Cardiology and Angiology II
Bad Krozingen
Cardiovascular Center Frankfurt (CVC Frankfurt)
Frankfurt, 60389
Klinik für Innere Medizin III
Homburg, 66421
About this study
Official title: First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study
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.
- Conditions
- Hypertension,Essential
- Being tested
- Catheter-Based Carotid Body Ablation
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-Based Carotid Body AblationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Catheter-Based Carotid Body Ablation | Experimental | All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS). Receives: Device: Catheter-Based Carotid Body Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by incidence of major adverse events
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, and any device or procedure-related serious adverse event.
Measured: From procedure to one month post-procedure
Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
Measured: Baseline versus six months post-procedure
Secondary outcomes (4)
Composite rate of major adverse events
Safety assessed as the combined rate of major adverse events defined as all-causes of death and hospitalization for hypertensive crisis not related to confirmed non-adherence with anti-hypertensive medications
Measured: At 6, 12, 18, and 24 months post-procedure
Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure
Measured: Baseline versus 3, 6, 12, 18, and 24 months
Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure
Controlled blood pressure is defined as office blood pressure <140/90 mmHg, mean 24-hr ABP <130/80 mmHg, daytime ABP <135/85 mmHg, and mean nighttime ABP <120/70 mmHg
Measured: At 6, 12, 18, and 24 months
Ventricular morphometric improvements from cardiac MRI measurements
Measured: Screening versus 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start11 Dec 2015
- Primary completionAug 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cibiem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Schlaich, Professor, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314012
- Sponsor's protocol ID
- CL1008
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03314012
- Acronym / sponsor ID
- CL1008
- Conditions
- Hypertension,Essential
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cibiem, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2015 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter-Based Carotid Body Ablation | Experimental | Device: Catheter-Based Carotid Body AblationAll subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter-Based Carotid Body AblationThe 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. | Device | Catheter-Based Carotid Body Ablation |
Primary outcome
Safety as assessed by incidence of major adverse events
Time frame: From procedure to one month post-procedure
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, and any device or procedure-related serious adverse event.
Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure
Time frame: Baseline versus six months post-procedure
4 secondary outcomes
Composite rate of major adverse events
Time frame: At 6, 12, 18, and 24 months post-procedure
Mean reduction in office systolic and diastolic blood pressure, and home systolic and diastolic blood pressure
Time frame: Baseline versus 3, 6, 12, 18, and 24 months
Proportion of subjects with controlled blood pressure at 6, 12, 18, and 24 months post-procedure
Time frame: At 6, 12, 18, and 24 months
Ventricular morphometric improvements from cardiac MRI measurements
Time frame: Screening versus 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schlaich, Professor principal investigator
Royal Perth Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter-Based Carotid Body Ablation in people with Hypertension,Essential, run by Cibiem, Inc. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Germany, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by incidence of major adverse events (time frame: From procedure to one month post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.