SMART Study in Real World

NCT06780696 | Not Yet Recruiting

• 1 other identifier: SMART-RW-2024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension; Uncontrolled Hypertension; Resistant Hypertension; Reduce Antihypertensive Drug Burden

Keywords

uncontrolled hypertension; hypertension; reduce antihypertensive medications; resistant hypertension

Outcome Measures

Primary Outcomes (1)

• Office systolic blood pressure (OSBP)

  The change in office systolic blood pressure between baseline and 6 months

  6 months

Secondary Outcomes (5)

• Office Blood Pressure

  1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months

• 24-hour Ambulatory Blood Pressure

  1, 3, 6, 12, 24 and 36 months

• Change in Antihypertensive Medications

  1, 3, 6, 12, 24 and 36 months

• Renal Function (eGFR and UACR)

  1, 3, 6, 12, 24 and 36 months

• Blood Glucos

  1, 3, 6, 12, 24 and 36 months

Other Outcomes (5)

• Success rate of msRDN procedure

  During the procedure

• Success rate of clinical treatment

  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

  1, 3, 6, 12, 24 and 36 months

Study Arms (2)

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.

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.

Interventions

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator DEVICE

Radiofrequency ablation of renal arterial sympathetic nerves

Prospective Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing renal denervation procedure for hypertension

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;
• 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.

Sponsors & Collaborators

• SyMap Medical (Suzhou), Ltd.: lead
• Beijing Hisicom Tech Dvpt Inc.: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100031, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Radionuclide Generators

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiation Equipment and Supplies; Equipment and Supplies

Study Officials

• JianPing LI, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie WANG, MD, PhD

CONTACT

+86-13511604566; jay329329@yahoo.com

JingJing ZHANG, BM

CONTACT

+8613914047970; jjzhang@symapmedical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)