Health TrialsbyHealthPanel

SMART-IC-Pilot Study

ConditionHypertensive Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSyMap Medical (Suzhou), Ltd.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

    Radiofrequency ablation of renal arterial sympathetic nerves

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Mapping/Selective Renal DenervationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in daytime ASBP

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

Time frame
From baseline to 2 months after RDN

Secondary outcomes

1

Change in office SBP

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

Time frame
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

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)
3

Change in 24-hr Ambulatory BP

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

Time frame
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;

Time frame
From baseline to 1, 2, 3 and 6 months after RDN

Other outcomes

1

Success rate of the renal interventional therapy procedure

The renal denervation catheter can be engaged to the correct position in renal artery, successfully performed renal nerve ablation procedure and has no related complications such as renal arterial perforation;

Time frame
Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first
2

Success rate of clinical treatment

Based on succeed performance of renal interventional therapy procedure , there are no the procedure-related SAE, such as acute infection and renal dysfunction. 7 days after the procedure or at the time the patient is discharged from hospital

Time frame
Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first
3

All-cause mortality

Time frame
From baseline to 1, 2, 3 and 6 months after RDN
4

Severe renal dysfunction (eGFR<15mL/min/m2 or renal function replacement therapy needed)

Time frame
From baseline to 6 months after RDN

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SyMap Medical (Suzhou), Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: