Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study
NCT ID: NCT01729988
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2012-11-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Carotid body excision
Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.
Carotid body excision
This surgery does not involve any study drug or investigational device.
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.
Interventions
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Carotid body excision
This surgery does not involve any study drug or investigational device.
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.
Eligibility Criteria
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Inclusion Criteria
* Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 \< AHI \< 30 with O2 desaturation not exceeding 80% during the night.
Exclusion Criteria
* Carotid body located outside the defined carotid septum
* Obstructive carotid atherosclerotic disease
* Oxygen desaturation at rest below 92%
* Known structural lung disease (medical interview)
* Requirement for oxygen therapy to maintain oxygen saturation
* Patients wish to participate in mountain climbing, skin diving or free diving
* Pregnancy or anticipation of pregnancy
* Palliative care/chemotherapy
* Acute coronary syndrome or unstable angina \< 6 months prior to procedure
* Use of exogenous insulin AND history of hypoglycemic unawareness
* Stroke or transient ischaemic attack (TIA), or myocardial infarction \< 6 months prior to procedure
* Expected life expectancy less that 24months due to other disease
* Intravenous drug use
* Excessive use of alcohol or sedatives (Alcohol intake \>28 units/week)
* Obesity (BMI \> 40)
* Upper airway or facial abnormalities
* Large neck circumference (\>43.2 cm men; \>40.6 cm women)
* Febrile illness within two weeks of participation
* Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.
18 Years
75 Years
ALL
No
Sponsors
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Noblewell
INDUSTRY
Responsible Party
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Principal Investigators
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Paul A. Sobotka, M.D.
Role: STUDY_DIRECTOR
Cibiem, Inc.
Locations
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Department of Hypertension and Diabetology, Medical University of Gdansk
Gdansk, , Poland
Countries
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Other Identifiers
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CBR-GDAPL-CIBIEM
Identifier Type: -
Identifier Source: org_study_id
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