NCT07336433

SMART-IC-Pilot Study

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: SyMap Medical (Suzhou), Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, single-arm, exploratory study enrolling 15 subjects across approximately four sites with a 6-month follow-up period. Subjects are patients with uncontrolled hypertension who receive 1-2 antihypertensive medications and have completed a minimum two-week medication wash-out period prior to enrollment, or patients with uncontrolled hypertension without medication therapy.

Conditions

• Hypertensive Disease

Interventions

Type	Name	Description
DEVICE	The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II	Radiofrequency ablation of renal arterial sympathetic nerves

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: China