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An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Subjects are treated with the renal denervation procedure after randomization. |
|
| Control | Other | Subjects randomized prior to enrollment closure were treated with sham renal denervation (angiography only). Once enrollment was closed and the protocol revised, no control subjects crossed-over. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation using the Symplicity Renal Denervation System | Device | Subjects randomized to the renal denervation group underwent angiography and renal denervation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reaching BP Goal | 6 months post-randomization | |
| Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months) | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kandzari, MD | Piedmont Heart Institute | Principal Investigator |
| Michael Weber, MD | SUNY Downstate College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States | ||
| Duke University Medical Center |
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| Sham Renal Denervation | Other | Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over. |
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| Renal Angiography | Device | Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized. |
|
| Durham |
| North Carolina |
| 27710 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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