A Real-World Study on the Treatment of Hypertension With Netrod-RDN Renal Artery Radiofrequency Ablation System

Shanghai Golden Leaf MedTec

Status: Invitation-only

Conditions: Hypertension

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

Study type: Observational

Funder types: Industry

Identifiers

NCT07273877

MLWY-S240801

Details and patient eligibility

About

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.

Full description

All the subjects who were enrolled and received RDN treatment were followed up until 36 months after the surgery. Blood pressure was measured and the antihypertensive effect was evaluated at regular intervals at 7 days after RDN or before discharge (whichever came first), 30 days (±7 days) after the surgery, 3 months (±14 days), 6 months (±30 days), 12 months (±30 days), 24 months (±30 days), and 36 months (±30 days) during the follow-up. Dynamic safety data monitoring was conducted for the subjects throughout the entire study process.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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.

Exclusion criteria

• 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.

Trial design

1,000 participants in 1 patient group

Refractory hypertension and hypertension with drug intolerance Patient

Description:

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.

Treatment:

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