Symplicity Spyral renal denervation in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry follows about 500 adults treated with the Symplicity Spyral renal denervation system to collect real-world outcomes over up to 36 months. Eligible participants are adults with resistant hypertension or antihypertensive drug intolerance who have already undergone renal denervation with the device and who consent to follow-up. The study collects office blood pressure, medication use, adverse events, and available renal function or imaging data without randomization or protocol-driven treatment changes. It is overseen by Medtronic Vascular and conducted at Zhongshan Hospital Fudan University to document long-term safety, efficacy, and durability in routine clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.