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RECRUITING

NCT07876479

The Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2026-07-09

Completion Date

2029-12

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Hypertension Resistant Hypertension

Interventions

PROCEDURE

Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016)

Catheter-based renal denervation (RDN) will be performed under digital subtraction angiography (DSA) guidance using the same Medtronic RDN016 single-use multielectrode renal artery radiofrequency ablation catheter in both study groups. Participants will be randomized in a 1:1 ratio to two ablation-duration strategies. 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 ablation site in the renal artery branches will be treated for 1 minute.

Inclusion Criteria: 1. Men or women aged 20 to 80 years, inclusive. 2. A history of hypertension for at least 3 months. 3. Clinic systolic blood pressure ≥150 mmHg and \<180 mmHg, and/or clinic diastolic blood pressure ≥90 mmHg, together with a 24-hour mean systolic blood pressure ≥140 mmHg and \<170 mmHg, as specified in the study protocol. 4. Patients receiving 1 to 3 standard antihypertensive medications at baseline, or patients who cannot tolerate antihypertensive medications because of contraindications or adverse drug reactions. 5. The participant or legally authorized representative is able to understand the study, and the participant voluntarily signs the written informed consent form. Exclusion Criteria: 1. Pregnancy. 2. Unilateral or bilateral renal artery anatomical abnormalities unsuitable for renal denervation, including renal artery stenosis \>50%, renal artery aneurysm, renal artery dysplasia, or renal artery diameter \<3 mm or \>8 mm. Four radiofrequency ablations in the main renal artery or an accessory renal artery are not permitted. 3. A solitary kidney, a history of kidney transplantation, or an estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m². 4. Secondary hypertension, including hypertension caused by primary aldosteronism, pheochromocytoma/paraganglioma, Cushing syndrome, hyperthyroidism, aortic coarctation, or renovascular disease. 5. Allergy to contrast media. 6. Major surgery or traumatic injury within 1 month before enrollment; acute coronary syndrome within 6 months before enrollment; or planned surgery or cardiovascular intervention within the next 6 months. 7. Orthostatic hypotension. 8. Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c \>8%. 9. Significant bleeding tendency or hematologic disorders, including a platelet count \<50 × 10⁹/L or an international normalized ratio (INR) \>1.5. 10. A history of deep vein thrombosis within 6 months. 11. Stroke or transient ischemic attack (TIA) within 3 months. 12. Severe peripheral vascular disease or an abdominal aortic aneurysm requiring surgical intervention. 13. Severe valvular heart disease or a condition likely to require surgical valve replacement during the study period. 14. A history of atrial fibrillation or multifocal atrial tachycardia within 6 months, or a history of pacemaker or implantable cardioverter-defibrillator (ICD) implantation. 15. A serious comorbid condition that may affect study participation or survival, such as malignancy or AIDS. 16. Acute or severe systemic infection. 17. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Locations (1)

Ruijin hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China