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| Name | Class |
|---|---|
| Helios Health Institute GmbH | OTHER |
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Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathetic denervation | Other | All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal sympathetic denervation | Procedure | All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | Difference in time in blood pressure target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation) | target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints | Time in target range months 7 to 9 | months 7 to 9 |
| Secondary endpoints | Change in conventional home blood pressure one week before renal denervation vs. 6 months after renal denervation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Fengler, Dr. med. | Heart Center Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Mainz Kardiologie I | Not yet recruiting | Mainz | Rheinland Pflanz | 55131 | Germany |
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| one week before renal denervation vs. 6 months after renal denervation |
| Secondary endpoints | Change in systemic sympathetic activity | up to 12 months |
| Heart Center Leipzig | Recruiting | Leipzig | Saxony | 04289 | Germany |
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