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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter-Based Carotid Body Ablation | Experimental | All subjects undergo catheter-based ablation of the carotid body using the Cibiem Transvenous Ultrasound System (CTUS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter-Based Carotid Body Ablation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From procedure to one month post-procedure |
| Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure | Baseline versus six months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Schlaich, Professor | Royal Perth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Fiona Stanley Hospital |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | At 6, 12, 18, and 24 months |
| Ventricular morphometric improvements from cardiac MRI measurements | Screening versus 12 and 24 months |
| Murdoch |
| Western Australia |
| 6150 |
| Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Na Homolce Hospital | Prague | 15030 | Czechia |
| Clinic Cardiology and Angiology II | Bad Krozingen | Germany |
| Cardiovascular Center Frankfurt (CVC Frankfurt) | Frankfurt | 60389 | Germany |
| Klinik für Innere Medizin III | Homburg | 66421 | Germany |