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RDN for Heart Failure
Sponsor: Shanghai Golden Leaf MedTec Co. Ltd
Summary
This is a single-center, prospective, single-arm clinical trial to evaluate the efficacy and safety of renal denervation (RDN) using a multi-channel radiofrequency ablation system in patients with symptomatic heart failure, including both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). The primary objective is to determine whether RDN can reduce serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from baseline to 6 months post-procedure, and improve functional exercise capacity as measured by the six-minute walk test (6MWT). Approximately 20 eligible participants will undergo the RDN procedure while continuing their optimal guideline-directed medical therapy for heart failure. Assessments will be performed at baseline (pre-procedure), and at 30 days, 3 months, and 6 months post-procedure. Key evaluations include NT-proBNP measurement, echocardiography, 6MWT, New York Heart Association (NYHA) functional class assessment, and safety monitoring for adverse events. The study aims to provide preliminary clinical evidence on the effects of multi-channel RDN on cardiac biomarkers, functional status, and safety in heart failure patients, and to explore its potential as an adjunctive therapy for this population.
Official title: Efficacy and Safety of Renal Denervation (RDN) for Heart Failure: A Single-Center, Prospective Cohort Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05-10
Completion Date
2027-09-13
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
Renal denervation
1. Procedure: Bilateral renal denervation (RDN) using the multi-channel radiofrequency ablation system. Device Description: The intervention utilizes the Netrod® Multi-Channel Radiofrequency Renal Denervation System, consisting of: (1) a radiofrequency generator (Model 26D1G) with temperature and impedance monitoring capabilities, and (2) a single-use multi-electrode ablation catheter (Model 26C6W127F115T) featuring six spiral-arranged electrodes. 2. Surgical Technique: The procedure is performed percutaneously via femoral artery access under digital subtraction angiography (DSA) guidance. The catheter is advanced to both renal arteries (bilateral treatment). Using the expandable mesh design, the six electrodes contact the arterial wall to deliver radiofrequency energy bilaterally to the main renal arteries, primary branches, and accessible accessory arteries.
Locations (1)
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China