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The study was prematurely discontinued due to the low rate of enrollment.
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The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.
This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.
This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.
A minimum of 30 patients will be enrolled in Europe
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure (BP) Measurements | Office BP; Ambulatory BP; Home BP | Up to 5 year FU |
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Inclusion Criteria:
Age ≥18 years or minimum age as required by local regulations.
Patient has been thoroughly informed about this registry and signed Informed Consent Form.
Patient with true resistant hypertension defined as:
Patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension.
Exclusion Criteria:
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Patients with uncontrolled hypertension entitled to receive renal sympathetic denervation treatment per routine hospital practice and according to relevant international, or country specific guidelines
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| Name | Affiliation | Role |
|---|---|---|
| José Ramon Rumoroso, Dr. | Hospital Galdakao | Principal Investigator |
| Palop López, Dr. | Hospital San Juan Alicante | Principal Investigator |
| Mauri, Dr. | Germans Trias i Pujol Hospital | Principal Investigator |
| Perez, Dr. | Hospital de Léon | Principal Investigator |
| Garcia, Dr. | Hospital Monteprincipe | Principal Investigator |
| Goicolea, Dr. | Hospital Puerta de Hierro | Principal Investigator |
| Goran Stankovic, Dr. | Clinical Center of Serbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Center of Serbia | Belgrade | Serbia | ||||
| Hospital Galdakao |
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| Galdakao |
| Spain |