Symplicity Spyral renal denervation in China

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

This registry will see if the Symplicity Spyral device is safe and provides lasting blood pressure lowering for people in China who had renal denervation for resistant high blood pressure or who cannot tolerate blood pressure medicines.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medtronic Vascular (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07081243 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with resistant hypertension (office SBP ≥140 mmHg on three or more antihypertensives including a diuretic for >3 months) or those intolerant to antihypertensive drugs who have been treated with the Symplicity Spyral device and can provide informed consent.

Not a fit: Patients with unsuitable renal artery anatomy (diameter <3 mm or >8 mm), fibromuscular dysplasia, prior renal artery stents, or those who have not received the Symplicity Spyral device are unlikely to be eligible or to benefit from this registry.

Why it matters

Potential benefit: If successful, the registry could show that Symplicity Spyral provides sustained blood pressure reduction with an acceptable long-term safety profile for patients with resistant hypertension.

How similar studies have performed: Prior clinical trials and registries of renal denervation, including earlier Symplicity programs, have shown blood pressure reductions and acceptable safety signals, but long-term real-world evidence is still building.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: Resistant Hypertension