"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN

NCT07273877 | Enrolling By Invitation

• 1 other identifier: MLWY-S240801
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational one, collecting real-world data generated in routine clinical treatment. The Netrod-RDN renal artery radiofrequency ablation system (including the renal artery radiofrequency ablation device and the disposable mesh renal artery radiofrequency ablation catheter) produced and provided by Shanghai Meiliweiye Medical Technology Co., Ltd. was used to perform percutaneous renal denervation (RDN) on patients with refractory hypertension and drug intolerance in the real world. Refractory hypertension is defined as patients whose blood pressure remains uncontrolled despite taking three or more antihypertensive drugs (including one diuretic) for more than three months; drug intolerance refers to patients who have contraindications to drugs or cannot tolerate drug administration due to adverse drug reactions.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)

  Time Frame: Baseline to Month 6 post-procedure.

Secondary Outcomes (10)

• Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)

  Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.

• Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP)

  Baseline to 3, 12, 24, and 36 months post-procedure

• Change from Baseline in Home Blood Pressure (including both systolic and diastolic BP)

  Time Frame: Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure.

• Change from Baseline in Antihypertensive Medication Load (calculated based on the dosage and types of antihypertensive agents).

  Baseline to Day 7 or hospital discharge (whichever occurs first), and Months 1, 3, 6, 12, 24, and 36 post-procedure.

• Proportion of Participants Achieving Blood Pressure Targets (Office, Home, and 24-hour Ambulatory; including both systolic and diastolic BP)

  At the same assessment time points as the above BP measurements (office, home, and 24-hour ambulatory BP).

Study Arms (1)

Refractory hypertension and hypertension with drug intolerance Patient

For patients who have been taking more than three types of antihypertensive drugs (including one diuretic) for more than 3 months and whose blood pressure has not been controlled adequately; drug intolerance refers to patients who cannot tolerate the medication due to drug contraindications or adverse drug reactions.

Device: Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure

Interventions

Percutaneous nephrolysis combined with sympathetic nerve ablation (RDN) procedure DEVICE

The disposable mesh renal artery radiofrequency ablation catheter is a spiral-arranged 6-point mesh system. Once The use of a meshed renal artery radiofrequency ablation catheter in combination with a dedicated renal artery radiofrequency ablation device delivers radiofrequency energy to the inner wall of the renal artery, generating appropriate high temperatures to damage or partially damage the renal sympathetic nerves. This device has real-time temperature, power and impedance monitoring functions, providing real-time ablation feedback. It also has the function of real-time recording of ablation data and saving the data.

Refractory hypertension and hypertension with drug intolerance Patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory hypertension and those with drug intolerance in the real world

You may qualify if:

• (1) Patients who have already used or are planning to use the Netrod-RDN renal artery radiofrequency ablation system for RDN surgery;
• (2) Patients understand the requirements and treatment of this clinical study, agree to follow the requirements of this clinical study for follow-up, and sign the informed consent form before undergoing any special examinations and operations related to the study.

You may not qualify if:

• Patients with contraindications for RDN surgery and/or those who the researchers consider unsuitable for RDN or who do not wish to participate in this study.

Sponsors & Collaborators

• Shanghai Golden Leaf MedTec Co. Ltd: lead

Study Sites (1)

Capital Medical University Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: December 10, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)