SMART-IC-Pilot Study

SyMap Medical

Status: Not yet enrolling

Conditions: Hypertensive Disease

Treatments: Device: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II

Study type: Interventional

Funder types: Industry

Identifiers

NCT07336433

SMART-IC-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Documented essential hypertension
3. Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction
4. Office BP ≥ 140/90 mmHg and < 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent
5. Documented daytime ASBP ≥ 135 mmHg and < 170 mmHg after 2-week washout
6. 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:

1. Main renal artery diameter < 4 mm or > 8 mm
2. Main renal artery length < 25 mm
3. Single functioning kidney
4. Presence of abnormal kidney (or secreting adrenal) tumors
5. Renal artery with aneurysm
6. Pre-existing renal stent or history of renal artery angioplasty
7. Prior renal denervation procedure
8. 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Mapping/Selective Renal Denervation

Experimental group

Description:

Mapping/Selective Renal Denervation

Treatment:

Device: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II