Symplicity China Study

NCT07081243 | Recruiting FDA Device

• 1 other identifier: MDT24050
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Changes in office blood pressure

  1, 3, 6, 12, 24 and 36 months post-procedure

• Changes in home blood pressure

  1, 3, 6, 12, 24 and 36 months post-procedure

• Changes in 24-hour ambulatory blood pressure

  1, 3, 6, 12, 24 and 36 months post-procedure

• Changes of Number of medications

  1, 3, 6, 12, 24 and 36 months post-procedure

• Changes of Medication burden

  1, 3, 6, 12, 24 and 36 months post-procedure

Interventions

Symplicity Spyral Renal Denervation System DEVICE

Symplicity Renal Denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with resistant hypertension or antihypertensive drug intolerance. 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. Drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects.

You may qualify if:

• 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.

You may not qualify if:

• At least one main renal artery with a diameter less than 3 mm or greater than 8 mm.
• Presence of fibromuscular dysplasia.
• Renal artery stent placement within 3 months prior to the procedure.
• 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.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 210000, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2031
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)