Clinical trial NCT06780696: SMART Study in Real World
Official title: Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertension
Uncontrolled Hypertension
Resistant Hypertension
Reduce Antihypertensive Drug Burden
Keywords: uncontrolled hypertension
hypertension
reduce antihypertensive medications
resistant hypertension
Lead sponsor: SyMap Medical (Suzhou), Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Hisicom Tech Dvpt Inc.
First posted: 2025-01-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing renal denervation procedure for hypertension

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.

Detailed description: 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:

* 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)

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:

* 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.

Eligibility criteria: 1. \*\*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.
2. \*\*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.
3. \*\*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;
4. \*\*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.

Primary outcomes:
measure: Office systolic blood pressure (OSBP)
timeFrame: 6 months
Secondary outcomes:
measure: Office Blood Pressure
timeFrame: 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months
measure: 24-hour Ambulatory Blood Pressure
timeFrame: 1, 3, 6, 12, 24 and 36 months
measure: Change in Antihypertensive Medications
timeFrame: 1, 3, 6, 12, 24 and 36 months
measure: Renal Function (eGFR and UACR)
timeFrame: 1, 3, 6, 12, 24 and 36 months
measure: Blood Glucos
timeFrame: 1, 3, 6, 12, 24 and 36 months
Other outcomes:
measure: Success rate of msRDN procedure
timeFrame: During the procedure
measure: Success rate of clinical treatment
timeFrame: wiwithin 7 days after the procedure or at the time the patient is discharged from hospital
measure: All-cause mortality and incidence of severe renal function impairment
timeFrame: 1, 3, 6, 12, 24 and 36 months
measure: Incidence of renal artery stenosis
timeFrame: 12, 24 and 36 months
measure: Incidence of adverse events
timeFrame: 1, 3, 6, 12, 24 and 36 months
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: JianPing LI, MD
role: PRINCIPAL_INVESTIGATOR
References: