SMART Study in Real World

Официальное название

Sympathetic Mapping and Ablation of Renal Nerves to Treat Uncontrolled Hypertension in Real World

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
  Radiofrequency ablation of renal arterial sympathetic nerves

Первичные конечные точки

• Office systolic blood pressure (OSBP) [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Office Blood Pressure [Срок оценки: 1, 3, 6 (diastolic blood pressure), 12, 24 and 36 months]
• 24-hour Ambulatory Blood Pressure [Срок оценки: 1, 3, 6, 12, 24 and 36 months]
• Change in Antihypertensive Medications [Срок оценки: 1, 3, 6, 12, 24 and 36 months]
• Renal Function (eGFR and UACR) [Срок оценки: 1, 3, 6, 12, 24 and 36 months]
• Blood Glucos [Срок оценки: 1, 3, 6, 12, 24 and 36 months]

Критерии участия

• \*\*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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06780696 · SMART-RW-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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