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

N/AEnrolling By InvitationNCT07273877

Shanghai Golden Leaf MedTec Co. Ltd1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Hypertension

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Time Frame: Baseline to Month 6 post-procedure.

Secondary Outcomes

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

Time frame: 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)

Time frame: 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: 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).

Time frame: 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)

Office BP target \<140/90 mmHg or \<130/80 mmHg; Home BP target \<135/85 mmHg; 24-hour ambulatory BP target \<130/80 mmHg.

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

24-hour Time in Target Range for Ambulatory Blood Pressure (percentage of time meeting daytime <135/85 mmHg and nighttime <120/70 mmHg thresholds)

Time frame: Months 6, 12, and 36 post-procedure.

Change from Baseline in SF-12 Health-Related Quality of Life Score (for heart failure subgroup only)

The SF-12 Health-Related Quality of Life Score includes Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, using a norm-based system and not bonded by an absolute maximum or minimum, a higher SF-12 score on either the PCS or the MCS means a better health-related quality of life. Comparing the SF-12 scores before and after treatment can evaluate the improvement of the treatment on patient's daily quality of life.

Time frame: Baseline to Months 12 and 36 post-procedure.

Change from Baseline in Six-Minute Walk Distance (meters; heart failure subgroup only)

Time frame: Baseline to Months 6, 12, 24, and 36 post-procedure.

Periprocedural major adverse event (MAE) rate

All-cause death; ESRD (eGFR \<15 mL/min/1.73 m² or initiation of dialysis) or CKD progression (\>50% decrease in eGFR or \>50% increase in serum creatinine from baseline); Major thromboembolic events causing end-organ damage or requiring intervention to prevent it; Major vascular complications requiring surgical or endovascular intervention, including renal artery perforation, dissection, aneurysm, etc., and access-site vascular complications requiring intervention (e.g., hematoma, bleeding, arteriovenous fistula, etc.); Hospitalization for hypertensive crisis or significant hypotension not attributable to poor adherence to antihypertensive therapy; New renal artery stenosis \>70% (confirmed by angiography).

Time frame: Baseline to 30 days post-procedure

Safety event rates

All-cause mortality; ESRD (CKD stage 5; eGFR \<15 mL/min/1.73 m²) or CKD progression (\>50% decrease in eGFR from baseline or \>50% increase in serum creatinine from baseline); Major thromboembolic events causing end-organ damage or requiring intervention to prevent it; Hospitalization for hypertensive crisis or clinically significant hypotension (not attributable to poor adherence to antihypertensives); New renal artery stenosis \>70% (confirmed by angiography); New-onset acute coronary syndrome (ACS); New stroke, transient ischemic attack (TIA), or other major cerebrovascular events; Rehospitalization for worsening heart failure (HF subgroup only).

Time frame: Baseline to Month 36 post-procedure