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Hypertensive DiseaseSMART-IC-PilotNCT07336433

SMART-IC-Pilot Study

A study testing The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II in people with Hypertensive Disease, run by SyMap Medical (Suzhou), Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertensive Disease
What is being tested?
The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
1 Jan 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie WANG, MD,PHD contact

+8613511604566

jay329329@yahoo.com

JingJing ZHANG, BM contact

+8613914047970

jjzhang@symapmedical.com

China1 site

  • Shanghai Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this 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

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.

Read the 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.

Being tested
The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter IIDevice

    Radiofrequency ablation of renal arterial sympathetic nerves

Study groups in NCT07336433
Study groupRoleWhat they receive
Mapping/Selective Renal DenervationExperimentalMapping/Selective Renal Denervation
Receives: Device: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in daytime ASBP

    mean change in average daytime ASBP from baseline to 2 months post-procedure.

    Measured: From baseline to 2 months after RDN

Secondary outcomes (4)

  1. Change in office SBP

    Change in Office Systolic BP from baseline to 1 month,2 months,3 months and 6 months post-procedure;

    Measured: From baseline to 1, 2, 3 and 6 months after RDN

  2. Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic)

    change in Average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) from baseline to 2 months and daytime ambulatory Diastolic BP from baseline to 2 months post procedure

    Measured: 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)

  3. Change in 24-hr Ambulatory BP

    Change in 24-hr Ambulatory BP from baseline to 6 months post-procedure

    Measured: From baseline to 6 months after RDN

  4. Change in anti-hypertensive Drugs

    Change in anti-hypertensive Drugs form baseline to 1 month、2 months、3 months and 6 months post-procedure;

    Measured: From baseline to 1, 2, 3 and 6 months after RDN

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336433
Sponsor's protocol ID
SMART-IC-2025
Acronym
SMART-IC-Pilot
Status last verified
Jan 2026
First submitted
18 Dec 2025
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II in people with Hypertensive Disease, run by SyMap Medical (Suzhou), Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie WANG, MD,PHD (+8613511604566, jay329329@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daytime ASBP (time frame: From baseline to 2 months after RDN). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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