Recruiting
Symplicity China Study
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.
ClinicalTrials.gov IDNCT07081243
PhaseNot Applicable
Enrollment500
SponsorMedtronic Vascular
Age18 Years
SexALL
Conditions studied
Resistant Hypertension
About this study
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.
Interventions
- Device: Symplicity Spyral Renal Denervation System — Symplicity Renal Denervation
Primary outcomes
- Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure. (6 months post-procedure)
Eligibility information
Inclusion Criteria:
1. Aged 18 years or older.
2. Patients diagnosed with resistant hypertension or antihypertensive drug intolerance and treated with Symplicity Spyral Renal Denervation System. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months; or drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects.
3. The patient voluntarily undergoes renal denervation; the patient has been informed of the observational nature of the study; the patient voluntarily provides written informed consent ("Patient Informed Consent Form") and willingly participates in the study.
Exclusion Criteria:
1. At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
2. Presence of fibromuscular dysplasia.
3. Renal artery stent placement within 3 months prior to the procedure.
4. Presence of Renal artery aneurysms.
5. Presence of more than 50% stenosis in any treatable vessel.
6. Pregnant.
7. Present of renal or adrenal tumors.
8. Iliac/femoral artery stenosis prevents catheter insertion.
Study locations
- Zhongshan Hospital Fudan University, Shanghai, Shanghai Municipality 210000 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.