Actively Recruiting
A Prospective, Single-group, Non-interventional, Observational Study to Evaluate the Long-term Safety, Efficacy, and Durability of Symplicity Spyral Renal Denervation System in China
Led by Medtronic Vascular · Updated on 2025-11-17
500
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety, effectiveness, and durability of the Symplicity Spyral Renal Denervation System in people with resistant hypertension or those who cannot tolerate antihypertensive drugs. This observational study will follow about 500 participants in China for up to 36 months after their treatment to better understand real-world outcomes. The study is sponsored by Medtronic Vascular and aims to track blood pressure changes and related effects over time. Participants have undergone treatment with the Symplicity Spyral Renal Denervation System, a medical device designed to help manage resistant hypertension by targeting the nerves in the renal arteries. This study does not involve assigning treatments but observes patients who have already received this procedure. The study will monitor participants at multiple time points: 1, 3, 6, 12, 24, and 36 months after their procedure. During the study, participants will have their blood pressure measured in the office, at home, and through 24-hour ambulatory monitoring. Researchers will also track changes in the number and burden of medications taken, as well as the proportion of patients achieving target blood pressure control. Safety events and other health outcomes will be recorded throughout the 36 months of follow-up. Participants will be asked to provide informed consent and voluntarily take part in the observational study, which will continue until December 2031.
CONDITIONS
Brief Title
Symplicity China Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with resistant hypertension or have intolerance to antihypertensive drugs
- Treated with Symplicity Spyral Renal Denervation System
- Resistant hypertension defined as office systolic blood pressure ≥140 mmHg despite lifestyle measures and three or more antihypertensive medications including a diuretic for over 3 months
- Patients voluntarily undergoing renal denervation and providing written informed consent
You will not qualify if you...
- At least one main renal artery with diameter less than 3 mm or greater than 8 mm
- Presence of fibromuscular dysplasia
- Renal artery stent placement within 3 months prior to procedure
- Presence of renal artery aneurysms
- More than 50% stenosis in any treatable vessel
- Pregnant
- Presence of renal or adrenal tumors
- Iliac or femoral artery stenosis preventing catheter insertion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive the Symplicity Spyral Renal Denervation System procedure.
1 procedure visit (in-person)
Duration - Up to 36 months post-procedure
Participants are observed for safety, efficacy, and durability of the renal denervation over time.
Visits at 1, 3, 6, 12, 24, and 36 months post-procedure (in-person and/or remote assessments)
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 210000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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