NCT07081243Recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 11 Nov 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Medtronic Vascular
- Diseases
- High blood pressure
- NCT number
- NCT07081243
What you commit to
- Study type: Observational
- Planned participants: 500
- From 11 Nov 2025 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Renal artery stent placement within 3 months prior to the procedure.
Other
- At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
- Presence of fibromuscular dysplasia.
- Presence of Renal artery aneurysms.
- Presence of more than 50% stenosis in any treatable vessel.
- Pregnant.
- Present of renal or adrenal tumors.
- Iliac/femoral artery stenosis prevents catheter insertion.
Who the study is looking for
- Aged 18 years or older.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.