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GSR real-world registry

Clinical data

With more than 3,000 patients enrolled, the
GLOBAL SYMPLICITY REGISTRY (GSR) is the largest
renal denervation (RDN) data set in the world.

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Alert Indications, Safety, and Warnings

Unmatched real-world data

The GLOBAL SYMPLICITY REGISTRY has demonstrated the safety and efficacy of the Symplicity™ blood pressure procedure in a variety of patients representative of daily clinical practice, making it a vital source of insights for patient selection. Signifcant blood pressure reductions were sustained out to three years in both office and 24-hr BP measures.1-3

Global RDN insights

Prof. Markus Schlaich discusses GLOBAL SYMPLICITY REGISTRY data for patients with resistant hypertension.

Safety results

The GLOBAL SYMPLICITY REGISTRY demonstrated procedural and long-term safety of the Symplicity blood pressure procedure through three years in patients from real clinical practice.1-3

Advancing the study of long-term results

GSR DEFINE is a prospective, multi-center, single-arm, non-interventional and open-label registry that will document the long-term safety and efficacy of the Symplicity blood pressure procedure.

  • 5,000 patients to be enrolled†
  • 300+ sites worldwide
  • One to fve years of follow-up
A report icon represents multiple randomized controlled trials for this procedure.

Multiple RCTS

The Symplicity procedure has demonstrated signifcant and safe blood pressure reductions in randomized controlled trials.5,6
Randomized controlled trials
An open book icon represents the breadth of clinical evidence for the Symplicity procedure.

Extensive clinical evidence

Find links to a wide range of research on the safety and efficacy of the Symplicity blood pressure procedure.
View clinical compendium
A clipboard icon represents the availability of resources for patient selection.

Select the right patients

See which types of patients could beneft from the Symplicity blood pressure procedure.

Explore patient selection
*

Compared to a modeled control group in the GLOBAL SYMPLICITY REGISTRY.

†

2,000 incremental patients to the GLOBAL SYMPLICITY REGISTRY.

1

Mahfoud F, Mancia G, Schmieder R, et al. Three-year safety and efficacy in the Global Symplicity Registry: Impact of antihypertensive medication burden on blood pressure reduction. Presented at PCR e-course 2020.

2

Mahfoud F, Mancia G, Schmieder R, et. al. Renal Denervation in high-risk patients with hypertension. Journal of the American College of Cardiology. 2020; 75(23): 2879 - 2888.

3

Mahfoud F, Mancia G, Schmieder R, et al. Three-year safety and efficacy in the Global Symplicity Registry: Subgroup Analysis. Presented at ESH 2019.

4

Schmieder R, Böhm M, Schlaich M, et al. Modeled Clinical Event Reductions at Three Years in High-Risk Hypertension Patients Treated with Renal Denervation. Presented at Deutsche Gesellschaft fur Kardiologie 2021.

5

Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. The Lancet 2020; Published online March 29, 2020.

6

Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. 2022; 399:1401-1410.