Table 1.
Characteristics of trials
| First Author/Trial | Year | Total Patients (Sham) | Follow-Up Duration (Months) | Type of Sham | Investigational Device | Primary Efficacy Outcome | Participating Centers | Enrolment Period | Trial Design |
|---|---|---|---|---|---|---|---|---|---|
| SYMPLICITY HTN-3 | 2014 | 171 | 6 | Renal Angiography | Symplicity Renal Denervation System (Medtronic) | Mean change in office systolic blood pressure from baseline to 6 months | 88 sites in the United States | October 2011 to May 2013 | Prospective, single-blind, randomized, sham-controlled trial |
| Desch et al. | 2015 | 36†/35‡ | 6 | Renal Angiography | Symplicity Flex Cathether (by Ardian Inc, Palo Alto, CA, USA) | Change in 24-hour systolic blood pressure at 6 months | Single-center, Leipzig, Germany | July 2012 to January 2014 | Sham-controlled, randomized, single-center trial |
| ReSet | 2016 | 33†/32‡ | 3 | Radiograph scan while the patient was sedated |
Symplicity Renal Denervation Catheter (Medtronic) |
Mean change in daytime systolic ambulatory blood pressure measurements from baseline to 3 months | Single-center, Skejby, Denmark | No information | Sham-controlled, double-blind, randomized single-center trial |
| RADIANCE-HTN SOLO | 2018 | 72 | 2 | Renal Angiography |
Paradise endovascular ultrasound renal denervation system |
Mean change in daytime ambulatory systolic blood pressure from baseline to 2 months | 21 centers in the USA and 18 in Europe | March 28, 2016 to December 28, 2017 | Multicenter, single-blind, randomized, sham-controlled trial |
| SPYRAL HTN-OFF MED Pivotal | 2020 | 165†/ 137*/130** | 3 | Renal Angiography | Symplicity Spyral multielectrode renal denervation catheter# and Symplicity G3 radiofrequency Generator$ | Change in mean 24-h systolic blood pressure from baseline to 3 months | 44 centers in Australia, Austria, Canada, Germany, Greece, Ireland, United Kingdom and United States of America | June 25, 2015 to October 15, 2019 | Prospective, single-blinded, sham-control trial |
| SPYRAL HTN-ON MED | 2018 | 42† / 39‡ | 6 | Renal Angiography | Symplicity Spyral multielectrode renal denervation catheter# and Symplicity G3 radiofrequency generator$ | Change in ambulatory blood pressure from baseline to 6 months | 25 centers in the USA, Germany, Japan, UK, Australia, Austria and Greece | July 22, 2015 to June 14, 2017 | Randomized, Single-blind, sham-control, proof-of-concept trial |
| REDUCE HTN: REINFORCE | 2020 | 17*/15** |
2 (8 weeks) |
Renal Angiography | Vessix Renal Denervation system | Mean reduction in average 24-h ambulatory systolic blood pressure by 8 weeks post-randomization | 12 centers in the United States | April 2015 to October 2017 | Prospective, multicenter, single blinded, randomized, controlled, pilot trial |
| REQUIRE | 2021 | 71†/ 66*/67** | 3 | Renal Angiography |
Paradise endovascular ultrasound renal denervation system |
Change in 24-hour ambulatory systolic blood pressure from baseline to 3 months | 53 centers in Japan and Korea | January 12, 2017 to March 31, 2020 | Multicenter, single-blind, randomized, sham-controlled trial |
| RADIANCE-HTN TRIO | 2021 | 67 | 2 | Renal Angiography |
Paradise endovascular ultrasound renal denervation system |
Change in daytime ambulatory systolic blood pressure from baseline to 2 months | 28 centers in Europe and 28 centers in USA | March 11, 2016 to March 13, 2020 | Multicenter, single-blind, randomized, sham-controlled trial |
† Randomized patients; ‡ Patients included in iTT analysis for both the outcomes “change in office blood pressure” and “change in 24 h ambulatory blood pressure”; * Patients included in iTT analysis for the outcome “change in office blood pressure”; ** Patients included in iTT analysis for the outcome “change in 24 h ambulatory blood pressure.”; # Medtronic; Galway, Ireland); $ (Medtronic; Minneapolis, MN, USA)