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SMART-IC-Pilot Study
Sponsor: SyMap Medical (Suzhou), Ltd.
Summary
This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.
Official title: EFS Study of the Renal Nerve Mapping/Selective Renal Denervation (msRDN) System in the Absence of Antihypertensive Medications: A Prospective, Multicentre, Single-Arm Exploratory Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II
Radiofrequency ablation of renal arterial sympathetic nerves
Locations (1)
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China