RecruitingNCT07081243

Symplicity China Study

A Prospective, Single-group, Non-interventional, Non-blinded, Observational Study to Evaluate the Long-term Safety, Efficacy, and Durability of Symplicity Spyral Renal Denervation System in China


Sponsor

Medtronic Vascular

Enrollment

500 participants

Start Date

Nov 11, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The Symplicity China study will evaluate the real-world long-term safety, efficacy, and durability of the Symplicity Spyral system in a population of approximately 500 renal denervation treated subjects with up to 36 months of follow up.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called the Symplicity China Study, is observing long-term outcomes in Chinese patients who have undergone a procedure called renal denervation — a minimally invasive catheter-based treatment that disrupts certain nerve signals to the kidneys — for either treatment-resistant high blood pressure or intolerance to blood pressure medications. **You may be eligible if...** - You are 18 or older - You have resistant hypertension (blood pressure remains above 140 mmHg despite taking three or more blood pressure medications, including a diuretic, for at least 3 months) OR you cannot tolerate blood pressure medications - You have undergone or are about to undergo a renal denervation procedure using the Symplicity Spyral system **You may NOT be eligible if...** - Your kidney arteries are too narrow or too wide for the procedure - You have fibromuscular dysplasia (an abnormal artery condition), renal artery stents placed recently, kidney or adrenal tumors, or significant artery blockages - You are pregnant - Your leg arteries are too narrow for a catheter to be inserted Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESymplicity Spyral Renal Denervation System

Symplicity Renal Denervation


Locations(1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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NCT07081243


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