Carotid Body Removal for the Treatment of Resistant Hypertension
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|ClinicalTrials.gov Identifier: NCT01745172|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Procedure: Carotid body excision||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carotid Body Removal for the Treatment of Chronic Diseases Characterized by Excessive Central Sympathetic Activity Including Resistant Hypertension: a Pilot Study.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Carotid body excision
Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.
Procedure: 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.
- Change of Blood Pressure [ Time Frame: Baseline and 3 months ]Change from Baseline Blood Pressure at 3 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745172
|Clinical Research and Imaging Centre (CRIC) and the Bristol Heart Institute (BHI), University Hospitals Bristol NHS Foundation Trust|
|Bristol, United Kingdom, BS2 8HW|
|Study Director:||Paul A. Sobotka, MD||Cibiem, Inc.|