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NOT YET RECRUITING
NCT07336433
NA

SMART-IC-Pilot Study

Sponsor: SyMap Medical (Suzhou), Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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