An interventional study of Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016) in Hypertension and Resistant Hypertension, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
Study Background and Rationale
Renal denervation (RDN) is an interventional treatment for hypertension that targets renal sympathetic nerves using catheter-based ablation. The duration of radiofrequency ablation may influence the treatment effect. However, whether extending the ablation duration in the main renal arteries results in greater blood pressure reduction remains to be determined.
This prospective, multicenter, randomized controlled study is designed to compare two RDN ablation strategies with different ablation durations in the main renal arteries, while maintaining the same ablation duration at each site in the renal artery branches.
Study Design and Population
A total of 220 eligible patients with hypertension will be enrolled and randomly assigned in a 1:1 ratio to Group 1 or Group 2.
Eligible participants will have a clinic systolic blood pressure of at least 150 mmHg but less than 180 mmHg and/or a diastolic blood pressure of at least 90 mmHg, together with a 24-hour mean systolic blood pressure of at least 140 mmHg but less than 170 mmHg. Participants will be receiving 1 to 3 standard antihypertensive medications, or will be unable to tolerate such medications because of contraindications or adverse drug reactions, according to the study eligibility criteria.
Study Interventions
All participants will undergo renal denervation under digital subtraction angiography (DSA) guidance using a radiofrequency ablation system and a single-use multielectrode renal denervation catheter.
Group 1: Each ablation site in the main renal arteries and their branches will receive radiofrequency ablation for 1 minute.
Group 2: Each ablation site in the main renal arteries will receive radiofrequency ablation for 2 minutes, while each ablation site in the renal artery branches will receive radiofrequency ablation for 1 minute.
The two groups will be compared to evaluate the effect of the different ablation durations on blood pressure reduction.
Follow-up and Outcome Assessment
All participants will be followed up at 1, 3, 6, and 12 months after the RDN procedure. Blood pressure and other prespecified clinical outcomes will be assessed according to the study protocol.
Study Objective
The primary objective is to determine whether extending the ablation duration at each site in the main renal arteries from 1 minute to 2 minutes provides greater blood pressure reduction. The findings are expected to provide clinical evidence to support the standardization and optimization of RDN procedural protocols.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 220 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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Exclusion Criteria:
Participants will undergo renal denervation (RDN) and radiofrequency ablation will be performed for 1 minute at each ablation site in both the main renal arteries and their branches.
Procedure: Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016)
Participants will undergo renal denervation (RDN) and radiofrequency ablation will be performed for 2 minutes at each ablation site in the main renal arteries and for 1 minute at each ablation site in the renal artery branches.
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.
Change in 24-Hour Mean Systolic Blood Pressure From Baseline to 6 Months
The change in 24-hour mean systolic blood pressure from baseline to 6 months after renal denervation (RDN).
Time frame: 6 months
Change in Mean Daytime Systolic Blood Pressure From Baseline to 6 Months
The change in mean daytime systolic blood pressure from baseline to 6 months after renal denervation (RDN), measured by 24-hour ambulatory blood pressure monitoring. Daytime is defined as 6:00 AM to 10:00 PM.
Time frame: 6 months
Change in Mean Nighttime Systolic Blood Pressure From Baseline to 6 Months
The change in mean nighttime systolic blood pressure from baseline to 6 months after RDN, measured by 24-hour ambulatory blood pressure monitoring. Nighttime blood pressure will be assessed according to the nighttime period defined in the study protocol.
Time frame: 6 months
Change in Office Systolic Blood Pressure From Baseline to 6 Months
The change in office systolic blood pressure from baseline to 6 months after RDN. Office blood pressure will be measured according to the study protocol.
Time frame: 6 months
Change in Office Diastolic Blood Pressure From Baseline to 6 Months
The change in office diastolic blood pressure from baseline to 6 months after RDN. Office blood pressure will be measured according to the study protocol.
Time frame: 6 months
Change in Antihypertensive Medication Burden From Baseline to 6 Months
The change in antihypertensive medication burden from baseline to 6 months after RDN. All antihypertensive medications will be recorded, including drug names, daily doses, dosing frequencies, and dose adjustments. Medication burden will be calculated as the sum of the ratios of the actual daily dose to the recommended maximum daily dose for each medication, based on the JNC 7 guidelines.
Time frame: 6 months
Change in Number and Dosage of Antihypertensive Medications From Baseline to 6 Months
The change in the number and dosage of antihypertensive medications from baseline to 6 months after RDN. The number of antihypertensive medications and the daily dose of each medication will be recorded and compared between baseline and 6 months.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 29 months is above that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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