Hypertensive Disease
Conditions
Brief 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.
Interventions
DEVICEThe SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II
Radiofrequency ablation of renal arterial sympathetic nerves
Sponsors
SyMap Medical (Suzhou), Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime ASBP | From baseline to 2 months after RDN | mean change in average daytime ASBP from baseline to 2 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in office SBP | From baseline to 1, 2, 3 and 6 months after RDN | Change in Office Systolic BP from baseline to 1 month,2 months,3 months and 6 months post-procedure; |
| Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) | 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 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 |
| Change in 24-hr Ambulatory BP | From baseline to 6 months after RDN | Change in 24-hr Ambulatory BP from baseline to 6 months post-procedure |
| Change in anti-hypertensive Drugs | From baseline to 1, 2, 3 and 6 months after RDN | Change in anti-hypertensive Drugs form baseline to 1 month、2 months、3 months and 6 months post-procedure; |
Other
| Measure | Time frame | Description |
|---|---|---|
| Success rate of clinical treatment | Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first | 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 |
| AEs, SAEs and severe cardio-cerebrovascular events | From baseline to1,3 and 6 months after RDN | — |
| Success rate of the renal interventional therapy procedure | Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first | 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; |
| All-cause mortality | From baseline to 1, 2, 3 and 6 months after RDN | — |
| Severe renal dysfunction (eGFR<15mL/min/m2 or renal function replacement therapy needed) | From baseline to 6 months after RDN | — |
| Rate of new-onset renal artery stenosis assessed (stenosis > 70% ) | From baseline to 2 and 6 months after RDN | — |
Countries
China
Contacts
Primary ContactJie WANG, MD,PHD
Backup ContactJingJing ZHANG, BM
Outcome results
None listed