No phaseRecruiting

The Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy (RDN-DA)

A Prospective, Multicenter, Randomized Controlled Study on the Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy

Sponsor
Ruijin Hospital (Academic or other)
Enrolment
220 planned
Conditions
Hypertension; Resistant Hypertension
Interventions
Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016)
Ages
adults, older adults
Registry
NCT07876479

Full record on ClinicalTrials.gov

From the registry

This is a prospective, multicenter, randomized controlled study designed to evaluate the effect of renal denervation (RDN) ablation duration on blood pressure reduction in patients with hypertension. A total of 220 eligible patients with hypertension will be randomly assigned in a 1:1 ratio to one of two treatment groups. All participants will undergo renal denervation using a radiofrequency ablation system and a single-use multielectrode renal denervation catheter. In Group 1, each ablation site in the main renal arteries and their branches will be treated for 1 minute. In Group 2, each ablation site in the main renal arteries will be treated for 2 minutes, while each site in the renal artery branches will be treated for 1 minute. The study aims to determine whether a longer ablation duration in the main renal arteries provides greater blood pressure reduction and clinical benefit. Participants will be followed up at 1, 3, 6, and 12 months after the procedure to assess blood pressure and clinical outcomes.

Primary outcomes

  • Change in 24-Hour Mean Systolic Blood Pressure From Baseline to 6 Months

History

  1. Study completion expected

  2. Primary completion expected

  3. Registered

  4. Started