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Not yet recruiting NCT07336433

SMART-IC-Pilot Study

No phase Interventional Hypertensive Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II.
Who it may be relevant to
Registry conditions: Hypertensive Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change in daytime ASBP [Time frame: From baseline to 2 months after RDN]
Secondary outcome measures (4)
  • Change in office SBP [Time frame: From baseline to 1, 2, 3 and 6 months after RDN]
  • Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) [Time frame: From baseline to 2 months after RDN (for both 24-hr and night-time SBP/DBP); From baseline to 2 months after RDN (for daytime DBP)]
  • Change in 24-hr Ambulatory BP [Time frame: From baseline to 6 months after RDN]
  • Change in anti-hypertensive Drugs [Time frame: From baseline to 1, 2, 3 and 6 months after RDN]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Documented essential hypertension
  • Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction
  • Office BP ≥ 140/90 mmHg and < 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent
  • Documented daytime ASBP ≥ 135 mmHg and < 170 mmHg after 2-week washout
  • Able and willing to comply with all study procedures and follow-up visit

Exclusion criteria

1.Renal artery anatomy on either side, unsuitable for treatment:

  • Main renal artery diameter < 4 mm or > 8 mm
  • Main renal artery length < 25 mm
  • Single functioning kidney
  • Presence of abnormal kidney (or secreting adrenal) tumors
  • Renal artery with aneurysm
  • Pre-existing renal stent or history of renal artery angioplasty
  • Prior renal denervation procedure
  • Renal artery stenosis ≥ 50% 2.Active infection within 7 days of procedure 3.Iliac/femoral artery stenosis precluding msRDN catheter insertion 4.Type I diabetes mellitus 5.eGFR <45 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula) 6.Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) 7.Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) 8.Documented confirmed episode(s) of stable or unstable angina 9.Documented repeat (> 1) hospitalization for hypertensive crisis within the prior 12 months 10.Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 11.Primary pulmonary hypertension 12.Documented contraindication or allergy to contrast medium not amenable to treatment 13.Limited life expectancy of < 1 year at the discretion of the Investigator 14.Known drug/alcohol dependence or inability to comply with study protocol Pregnant, breastfeeding or intend to become pregnant within 12 months -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07336433 · SMART-IC-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗