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This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication. |
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| Optimal Medical Therapy | No Intervention | Subjects randomized to the control arm will be maintained on antihypertensive medications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation (OneShotâ„¢ Renal Denervation System) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Major adverse event (MAE) rate through 30 days post randomization | 30 days | |
| Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Safety | 30 days | |
| Chronic procedural safety | 6 months | |
| Reduction in SBP by >10 mmHg at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dierk Scheinert, MD | Park-Krankenhaus Liepzig | Principal Investigator |
| Guiseppe Mancia, MD | Universita Minano-Bicocca, Ospedale San Gerardo di Monza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Raffaele | Milan | Italy |
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| 6 months |
| Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits | 6, 12, 24, and 36 months |