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NCT Number: NCT07081243

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 210000, China

Location status: Recruiting

Location contact

Zhifeng Yao

CONTACT

[email protected]

0086-21-64041990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Symplicity Spyral Renal Denervation System

Device

Symplicity Renal Denervation

Primary outcomes

  1. Primary Objective: Change in systolic blood pressure (SBP) from baseline to 6 months post-procedure as measured by office blood pressure.

    Time frame: 6 months post-procedure

Secondary outcomes

  1. Changes in office blood pressure

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

  2. Changes in home blood pressure

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

  3. Changes in 24-hour ambulatory blood pressure

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

  4. Changes of Number of medications

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

  5. Changes of Medication burden

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

  6. Proportion of subjects achieving blood pressure reduction and control to ≤140 mmHg (measured by OBP, HBP, and ABPM)

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

  7. Event rates

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

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Jul 23, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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