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
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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
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Select the right patients

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

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*

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.

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