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NCT02761811: SMART

Sympathetic Mapping/ Ablation of Renal Nerves Trial

Active, enrolled NA Last updated 2 August 2023
What this trial tests

NA trial testing SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator in Hypertension in 220 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
30 June 2016
Primary endpoint
25 August 2022
31 December 2026

Quick facts

Lead sponsorSyMap Medical (Suzhou), Ltd.
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment220
Start date30 June 2016
Primary completion25 August 2022
Estimated completion31 December 2026
Sites15 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

SyMap Medical (Suzhou), Ltd.

Who can join

Adults 18 to 65, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Renal Denervation in Asia: Consensus Statement of the Asia Renal Denervation Consortium.
    Kario K, Kim BK, Aoki J, Wong AY, et al · · 2020 · cited 54× · PMID 32008432 · DOI 10.1161/hypertensionaha.119.13671
  2. Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial.
    Wang J, Yin Y, Lu C, Lu Z, et al · · 2024 · cited 20× · PMID 38756107 · DOI 10.1016/j.eclinm.2024.102626
  3. Renal denervation in the management of hypertension.
    Lauder L, Kandzari DE, Lüscher TF, Mahfoud F. · · 2024 · cited 11× · PMID 38629418 · DOI 10.4244/eij-d-23-00836
  4. Rationale and Design of Sympathetic Mapping/Ablation of Renal Nerves Trial (SMART) for the Treatment of Hypertension: a Prospective, Multicenter, Single-Blind, Randomized and Sham Procedure-Controlled Study.
    Wang J, Sun N, Ge J, Jiang H, et al · · 2023 · cited 9× · PMID 36042146 · DOI 10.1007/s12265-022-10307-z
  5. Renal Denervation Effects on Blood Pressure in Resistant and Uncontrolled Hypertension: A Meta-Analysis of Sham-Controlled Randomized Clinical Trials.
    Soleimani H, Sattartabar B, Parastooei B, Eshraghi R, et al · · 2025 · cited 3× · PMID 40022571 · DOI 10.1002/clc.70104
  6. Present Evidence of Determinants to Predict the Efficacy of Renal Denervation.
    Zhou H, Xu Y, Chen W, Wang L, et al · · 2022 · cited 1× · PMID 35992203 · DOI 10.1155/2022/5694127
  7. A scoping review of neuromodulation techniques for controlling blood pressure: what are the ups and downs to this approach?
    Greechan PL, Koh RGL, Yoo PB. · · 2025 · PMID 40814063 · DOI 10.1186/s42234-025-00181-w

Verify or expand the search:

Other trials of SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Trials testing the same drug.

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other SyMap Medical (Suzhou), Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02761811.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing