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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid body ablation | Experimental | Patients undergoing the unilateral endovascular ablation of the right or left carotid body. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid body ablation (Cibiem) | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Blood Pressure | Change from Baseline Blood Pressure at 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital, Roentgenova 2 | Prague | 150 30 | Czechia | |||
| Department of Hypertension and Diabetology, Medical University of Gdansk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Gdansk |
| 80-952 |
| Poland |