HypertensionSMART-RWNCT06780696
SMART Study in Real World
An observational study of Hypertension and Uncontrolled Hypertension, run by SyMap Medical (Suzhou), Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Uncontrolled Hypertension, Resistant Hypertension
- What is being tested?
- SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing renal denervation procedure for hypertension
- Inclusion Criteria (for A. Prospective Cohort)
- Patients are ≥18 years old;
- Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications;
- Patients consent to receive msRDN treatment using the commercially available msRDN system by SyMap Medical (Suzhou), Ltd and to fulfill follow-up requirements.
- Exclusion Criteria (for A. Prospective Cohort)
- Subjects are withdrawn from the study due to various reasons;
- Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.
- Inclusion Criteria (for B. Retrospective Cohort)
- Patients are ≥18 years old;
- Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications;
- Patients who have been received msRDN procedure using commercially available msRDN system by SyMap Medical (Suzhou), Ltd;
- Exclusion Criteria (for B. Retrospective Cohort)
- Subjects are withdrawn from the study due to various reasons;
- Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100031
Wei MA, MD
About this study
Official title: Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World
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.
Read the detailed description
- 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:
- Visit 0: Baseline/Screening Period
- Visit 1: msRDN procedure (Day 0)
- Visit 2: 1 Month Post-msRDN (30 ± 7 days)
- Visit 3: 3 Months Post-msRDN (90 ± 14 days)
- Visit 4: 6 Months Post-msRDN (180 ± 30 days)
- Visit 5: 12 Months Post-msRDN (360 ± 30 days)
- Visit 6: 24 Months Post-msRDN (720 ± 30 days)
- Visit 7: 36 Months Post-msRDN (1080 ± 30 days)
- 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:
- Visit 1: msRDN procedure (Day 0)
- Visit 2: 1 Month Post-msRDN (30 ± 14 days)
- Visit 3: 3 Months Post-msRDN (90 ± 28 days)
- Visit 4: 6 Months Post-msRDN (180 ± 28 days)
- Visit 5: 12 Months Post-msRDN (360 ± 28 days)
- Visit 6: 24 Months Post-msRDN (720 ± 28 days)
- Visit 7: 36 Months Post-msRDN (1080 ± 28 days) Final Follow-Up
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.
- Conditions
- Hypertension, Uncontrolled Hypertension, Resistant Hypertension, Reduce Antihypertensive Drug Burden
- Being tested
- SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
- Keywords
- uncontrolled hypertension, hypertension, reduce antihypertensive medications, resistant hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorDevice
Radiofrequency ablation of renal arterial sympathetic nerves
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office systolic blood pressure (OSBP)
The change in office systolic blood pressure between baseline and 6 months
Measured: 6 months
Secondary outcomes (5)
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;
Measured: 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months
24-hour Ambulatory Blood Pressure
Changes in 24-hour ambulatory blood pressure (systolic and diastolic) between baseline and 1, 3, 6, 12, 24 and 36 months, respectively;
Measured: 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;
Measured: 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;
Measured: 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
Measured: 1, 3, 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hisicom Tech Dvpt Inc.
- Responsible party
- Sponsor
- Investigators
- JianPing LI, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780696
- Sponsor's protocol ID
- SMART-RW-2024
- Acronym
- SMART-RW
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World
- ClinicalTrials.gov ID
- NCT06780696
- Acronym / sponsor ID
- SMART-RW / SMART-RW-2024
- Conditions
- Hypertension, Uncontrolled Hypertension, Resistant Hypertension, Reduce Antihypertensive Drug Burden
- Keywords
- uncontrolled hypertension, hypertension, reduce antihypertensive medications, resistant hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Hisicom Tech Dvpt Inc.
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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:
- Visit 0: Baseline/Screening Period
- Visit 1: msRDN procedure (Day 0)
- Visit 2: 1 Month Post-msRDN (30 ± 7 days)
- Visit 3: 3 Months Post-msRDN (90 ± 14 days)
- Visit 4: 6 Months Post-msRDN (180 ± 30 days)
- Visit 5: 12 Months Post-msRDN (360 ± 30 days)
- Visit 6: 24 Months Post-msRDN (720 ± 30 days)
- Visit 7: 36 Months Post-msRDN (1080 ± 30 days)
- 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:
- Visit 1: msRDN procedure (Day 0)
- Visit 2: 1 Month Post-msRDN (30 ± 14 days)
- Visit 3: 3 Months Post-msRDN (90 ± 28 days)
- Visit 4: 6 Months Post-msRDN (180 ± 28 days)
- Visit 5: 12 Months Post-msRDN (360 ± 28 days)
- Visit 6: 24 Months Post-msRDN (720 ± 28 days)
- Visit 7: 36 Months Post-msRDN (1080 ± 28 days) Final Follow-Up
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Study | – | Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing renal denervation procedure for hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorRadiofrequency ablation of renal arterial sympathetic nerves | Device | Prospective Study |
Primary outcome
Office systolic blood pressure (OSBP)
Time frame: 6 months
The change in office systolic blood pressure between baseline and 6 months
5 secondary outcomes
Office Blood Pressure
Time frame: 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months
24-hour Ambulatory Blood Pressure
Time frame: 1, 3, 6, 12, 24 and 36 months
Change in Antihypertensive Medications
Time frame: 1, 3, 6, 12, 24 and 36 months
Renal Function (eGFR and UACR)
Time frame: 1, 3, 6, 12, 24 and 36 months
Blood Glucos
Time frame: 1, 3, 6, 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JianPing LI, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Uncontrolled Hypertension, run by SyMap Medical (Suzhou), Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie WANG, MD, PhD (+86-13511604566, jay329329@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office systolic blood pressure (OSBP) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.