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To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symplicty(TM) Catheter System | Device | Renal denervation using the Symplicity Catheter System |
| Measure | Description | Time Frame |
|---|---|---|
| To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To document the physiologic effects of renal denervation in patients with refractory hypertension. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Krum, PhD | Monash University and The Alfred Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany | ||||
| St. Elisabeth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24210779 | Derived | Krum H, Schlaich MP, Sobotka PA, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R, Esler MD. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014 Feb 15;383(9917):622-9. doi: 10.1016/S0140-6736(13)62192-3. Epub 2013 Nov 7. | |
| 23780578 | Derived |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Bochum |
| Germany |
| Klinikum Coburg | Coburg | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | Germany |
| University of Erlangen at Nuremburg | Erlangen | Germany |
| CardioVascular Center Frankfurt, Sankt Katharinen | Frankfurt | Germany |
| Clinical Trial Center North | Hamburg | Germany |
| Universitatskliniken des Saarlandes | Homburg | Germany |
| University of Leipzig - Herzzentrum | Leipzig | Germany |
| Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Bohm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013 Jul 9;128(2):132-40. doi: 10.1161/CIRCULATIONAHA.112.000949. Epub 2013 Jun 18. |
| 21518978 | Derived | Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25. |
| 19332353 | Derived | Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28. |