HypertensionNCT02099851
Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study
A study testing Carotid body ablation (Cibiem) in people with Hypertension, run by Noblewell at 2 sites in 2 countries.
Trial summary
This is a prospective, observational, multicenter trial to evaluate the safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension. All patients will be followed for two (2) years following treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Carotid body ablation (Cibiem)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Dec 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of participants will be 18-75 years.
- Treatment-resistant hypertensive subjects on medical management.
- Office systolic blood pressure (oBP) ≥ 160mmHg.
- Daytime mean ambulatory BP (ABPM) ≥ 140 mmHg.
- Persistent hypertension on at least three anti-hypertensive medications, including a diuretic, at stable, maximum tolerated dose within the last 90 days.
- No evidence for causes of secondary HTN (hypertension ) following thorough clinical assessment.
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- At least one carotid body detected in CT angiography of the neck, defined as an hyper-enhanced ovoid structure strongly located poster-medially from the area of carotid bifurcation.
- Ability to give and giving informed consent to participate in the study.
- Women of child-bearing potential have a negative pregnancy test.
Who cannot join
- Calculated GFR (glomerular filtration rate) < 30ml/min/m2
- Obstructive carotid atherosclerotic disease which precludes safe delivery of ablation catheter or performance of ablation
- Must be at least 6 months post renal denervation therapy.
- Oxygen saturation at rest below 92%.
- Requirement for oxygen therapy to maintain oxygen saturation.
- Severe untreated obstructive sleep apnea (defined as an apnea-hypopnea index (AHI) ≥ 30/hour during Polysomnography associated with an average minimum oxygen desaturation of < 85%.
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- Patients wish to participate in mountain climbing, sky diving or free diving.
- Pregnancy or anticipation of pregnancy.
- Acute coronary syndrome or unstable angina < 6 months before scheduled procedure.
- History of repeated episodes of hypoglycemia with hypoglycemic unawareness.
- Known diabetic autonomic neuropathy.
- History of, or current atrial fibrillation (AF).
- Life expectancy of less than 24 months due to other disease.
- Intravenous or inhaled recreational drug use.
- Excessive use of alcohol or sedatives (alcohol intake > 28 units/week).
- Morbid obesity (BMI >40).
- Febrile illness within two weeks of participation.
- History of Stroke, transient ischaemic attack (TIA) or significant chronic neurological condition in medical history.
- History of spontaneous intracranial hemorrhage within past 12 months.
- Unable to tolerate exposure to the radiopaque contrast agent.
- Unable to tolerate aspirin and/or other anti-coagulation; anti-platelet medication.
- Femoral arterial access is not possible.
- Presence of carotid artery dissection prior to the index procedure.
- Atherosclerotic disease involving vessels adjoining the carotid body, marked vessel tortuosity or other anatomical findings that preclude safe placement of the guiding catheter or the investigational system, and the delivery of RF energy.
- Carotid body is not within reach of the investigational system due to position within the carotid bifurcation or distance of the CB (carotid body) from the femoral access point.
- Other abnormal angiographic findings that indicate the patient is at risk of a stroke, such as carotid or intracranial aneurysm, arteriovenous malformation (AVM), other developmental or traumatic vascular lesion or tumor.
- Dementia or confusion precluding the patient's full understanding of the information required for informed consent and full participation in the study.
- Unable to attend schedule follow up appointments at one (1)_month, three (3) months, six (6) months, one (1) year and two (2) years post treatment.
- History of gastrointestinal bleeding within the last six (6) months.
- Active or treated malignancies in the last twelve (12) months.
- Patient is participating in another clinical study for which follow-up is currently on going.
- Patient with non-cardiac co-morbidities and life expectancy < 2 year.
- Patient has a condition that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site
Department of Hypertension and Diabetology, Medical University of Gdansk
Gdansk, 80-952
About this study
Official title: Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study.
This is a prospective, observational, multicenter trial to evaluate the safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension. All patients will be followed for two (2) years following treatment.
Read the detailed description
The investigators propose a new method of treatment, unilateral carotid body ablation, for treatment- resistant hypertensive patients to restore more normal blood pressure control, which will reduce cardiovascular morbidity and mortality in these patients. This strategy will increase the number of therapeutic options available to many patients and their physicians as well as offering the potential of normal blood pressure to those patients in whom blood pressure remains elevated despite vigorous, drug or device based therapies.
- Conditions
- Hypertension
- Being tested
- Carotid body ablation (Cibiem)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid body ablation (Cibiem)Device
Also called Cibiem Carotid Body Modulation System
| Study group | Role | What they receive |
|---|---|---|
| Carotid body ablation | Experimental | Patients undergoing the unilateral endovascular ablation of the right or left carotid body. Receives: Device: Carotid body ablation (Cibiem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension employing a radiofrequency catheter designed specifically for this indication.
Measured: 3 months
Secondary outcomes (1)
Change of Blood Pressure
Change from Baseline Blood Pressure at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099851
- Sponsor's protocol ID
- CL1003-CIBIEM
- Status last verified
- Oct 2016
- First submitted
- 26 Mar 2014
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study.
- ClinicalTrials.gov ID
- NCT02099851
- Acronym / sponsor ID
- CL1003-CIBIEM
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 31 Mar 2014 (estimated)
- 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.
This is a prospective, observational, multicenter trial to evaluate the safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension. All patients will be followed for two (2) years following treatment.
Detailed description
The investigators propose a new method of treatment, unilateral carotid body ablation, for treatment- resistant hypertensive patients to restore more normal blood pressure control, which will reduce cardiovascular morbidity and mortality in these patients. This strategy will increase the number of therapeutic options available to many patients and their physicians as well as offering the potential of normal blood pressure to those patients in whom blood pressure remains elevated despite vigorous, drug or device based therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid body ablation | Experimental | Device: Carotid body ablation (Cibiem)Patients undergoing the unilateral endovascular ablation of the right or left carotid body. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of participants will be 18-75 years.
- Treatment-resistant hypertensive subjects on medical management.
- Office systolic blood pressure (oBP) ≥ 160mmHg.
- Daytime mean ambulatory BP (ABPM) ≥ 140 mmHg.
- Persistent hypertension on at least three anti-hypertensive medications, including a diuretic, at stable, maximum tolerated dose within the last 90 days.
Key exclusion criteria (33 listed)
- Calculated GFR (glomerular filtration rate) < 30ml/min/m2
- Obstructive carotid atherosclerotic disease which precludes safe delivery of ablation catheter or performance of ablation
- Must be at least 6 months post renal denervation therapy.
- Oxygen saturation at rest below 92%.
- Requirement for oxygen therapy to maintain oxygen saturation.
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 |
|---|---|---|
| Carotid body ablation (Cibiem)Also: Cibiem Carotid Body Modulation System | Device | Carotid body ablation |
Primary outcome
Adverse events
Time frame: 3 months
Safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension employing a radiofrequency catheter designed specifically for this indication.
1 secondary outcome
Change of Blood Pressure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid body ablation (Cibiem) in people with Hypertension, run by Noblewell at 2 sites in 2 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 9 inclusion and 33 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Poland. 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?
Adverse events (time frame: 3 months). 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 17 Oct 2016.