Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study

October 14, 2016 updated by: Noblewell

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 150 30
        • Na Homolce Hospital, Roentgenova 2
  • Poland
      • Gdansk, Poland, 80-952
        • Department of Hypertension and Diabetology, Medical University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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%.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Carotid body ablation
Patients undergoing the unilateral endovascular ablation of the right or left carotid body.
Device: Carotid body ablation (Cibiem)
Other Names:
  • Cibiem Carotid Body Modulation System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Blood Pressure
Time Frame: 3 months
Change from Baseline Blood Pressure at 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noblewell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL1003-CIBIEM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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