Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Hisicom Tech Dvpt Inc. | UNKNOWN |
Not provided
Not provided
Not provided
This study is a multicenter, single-arm, open-label and post-market study in a real world patient population with uncontrolled hypertension to document the long-term safety and efficacy of a renal mapping/selective renal denervation (msRDN) system (SyMap Medical (Suzhou), Ltd, Suzhou, China) and conducted in accordance with the requirements by National Medical Production Administration (NMPA) of China. The msRDN system consists of a disposable renal artery radiofrequency ablation catheter (Registration No: National Medical Device Approval 20243011383), a console with both electronic stimulation and radiofrequency ablation function (Registration No: National Medical Device Approval 20243011384). The study includes prospective cohort and retrospective cohort.
Approximately1,000 patients with uncontrolled hypertension who undergo msRDN procedure will be recruited from over 30 centers in China. Subjects enrolled in the study will be followed for at least three years after msRDN procedure. This study includes patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications per the inclusion criteria defined in the protocol.
A. **Prospective Study: ** In this cohort, the long-term safety and efficacy of the approved msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications.
Study Period and Timeline (for A. Prospective Cohort)**
Subjects included in this post-market, real-world study will be followed for at least three years after msRDN procedure. The regarding clinical parameters will be taken at baseline and at each follow-up as below:
B. **Retrospective Study:** In this cohort, the safety and efficacy of msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications, who have been treated by msRDN procedure.
*Study Period and Timeline (for B. Retrospective Cohort) ** Patients who have been consented and enrolled in the study will be followed for at least three years.
In this cohort, as long as a patient meets inclusion criteria of the study and at least one clinical efficacy endpoint is recorded at ≥36 months after msRDN procedure, the data from this patient will be used for statistical analysis. During 36 month study period, data will be collected at baseline and at each follow-up point per protocol as below:
The midpoints of two adjacent follow-ups are used as the reference to determine which follow-up point the data belong to: if data are collected before the midpoint and accounted in the early follow-up;if data are collected after the midpoint and accounted in the later follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Study | In this cohort, the long-term safety and efficacy of the approved msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications. |
| |
| Retrospective Study | In this cohort, the safety and efficacy of msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications, who have been treated by msRDN procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator | Device | Radiofrequency ablation of renal arterial sympathetic nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Office systolic blood pressure (OSBP) | The change in office systolic blood pressure between baseline and 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Office Blood Pressure | Changes in office blood pressure (systolic and diastolic) between baseline and 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months, respectively; | 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months |
| 24-hour Ambulatory Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of msRDN procedure | The success rate was defined by whether the renal mapping/denervation catheter can be engaged in the correct position in the renal artery and renal nerve ablation procedure was successfully performed without related complications such as renal arterial perforation or renal artery embolization. | During the procedure |
**Inclusion Criteria (for A. Prospective Cohort)**
**Exclusion Criteria (for A. Prospective Cohort)**
**Inclusion Criteria (for B. Retrospective Cohort)**
**Exclusion Criteria (for B. Retrospective Cohort) **
Not provided
Not provided
Not provided
Subjects undergoing renal denervation procedure for hypertension
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie WANG, MD, PhD | Contact | +86-13511604566 | jay329329@yahoo.com | |
| JingJing ZHANG, BM | Contact | +8613914047970 | jjzhang@symapmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| JianPing LI, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011876 | Radionuclide Generators |
| ID | Term |
|---|---|
| D055618 | Radiation Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Changes in 24-hour ambulatory blood pressure (systolic and diastolic) between baseline and 1, 3, 6, 12, 24 and 36 months, respectively; |
| 1, 3, 6, 12, 24 and 36 months |
| Change in Antihypertensive Medications | Changes in antihypertensive medications between baseline and 1, 3, 6, 12, 24 and 36 months, respectively; | 1, 3, 6, 12, 24 and 36 months |
| Renal Function (eGFR and UACR) | Changes in renal function (eGFR and UACR) between baseline and 1, 3, 6, 12, 24 and 36 months, respectively; | 1, 3, 6, 12, 24 and 36 months |
| Blood Glucos | Changes in blood glucose level between baseline and 1, 3, 6, 12, 24 and 36 months, respectively | 1, 3, 6, 12, 24 and 36 months |
| Success rate of clinical treatment |
Based on succeed performance of msRDN procedure, there are no the procedure-related SAE, such as acute infection and renal dysfunction |
| wiwithin 7 days after the procedure or at the time the patient is discharged from hospital |
| All-cause mortality and incidence of severe renal function impairment | eGFR < 15 mL/min/m² or requiring renal replacement therapy at 1, 3, 6, 12, 24 and 36 months after msRDN procedure; | 1, 3, 6, 12, 24 and 36 months |
| Incidence of renal artery stenosis | Incidence of renal artery stenosis (stenosis>70%) at 12, 24 and 36 months after msRDN procedure; | 12, 24 and 36 months |
| Incidence of adverse events | Incidence of adverse events and serious adverse events at 1, 3, 6, 12, 24 and 36 months after msRDN procedure. | 1, 3, 6, 12, 24 and 36 months |