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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mapping/Selective Renal Denervation | Experimental | Mapping/Selective Renal Denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II | Device | Radiofrequency ablation of renal arterial sympathetic nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in daytime ASBP | mean change in average daytime ASBP from baseline to 2 months post-procedure. | From baseline to 2 months after RDN |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office SBP | Change in Office Systolic BP from baseline to 1 month,2 months,3 months and 6 months post-procedure; | From baseline to 1, 2, 3 and 6 months after RDN |
| Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first |
Inclusion Criteria:
Exclusion Criteria:
1.Renal artery anatomy on either side, unsuitable for treatment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie WANG, MD,PHD | Contact | +8613511604566 | jay329329@yahoo.com | |
| JingJing ZHANG, BM | Contact | +8613914047970 | jjzhang@symapmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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
| 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 | Change in 24-hr Ambulatory BP from baseline to 6 months post-procedure | From baseline to 6 months after RDN |
| Change in anti-hypertensive Drugs | Change in anti-hypertensive Drugs form baseline to 1 month、2 months、3 months and 6 months post-procedure; | From baseline to 1, 2, 3 and 6 months after RDN |
| 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 | Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first |
| 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 |
| AEs, SAEs and severe cardio-cerebrovascular events | From baseline to1,3 and 6 months after RDN |