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Symplicity China Study | Clinical Trials | Clareo Health

RECRUITING

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

NCT07081243•Medtronic Vascular

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 11, 2025

Primary Completion Date

June 30, 2028

Completion Date

December 30, 2031

Last Updated

November 17, 2025

Enrollment

500

ESTIMATED participants

Conditions

Resistant Hypertension

Interventions

Symplicity Spyral Renal Denervation System

DEVICE

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Endocalyx in Treatment Resistent Hypertension

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Evaluation of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Symplicity China Study

Inclusion Criteria

Exclusion Criteria

Endothelin-1 Receptor Blockade in Resistant Hypertension

Endocalyx in Treatment Resistent Hypertension

Evaluation of Two Isometric Exercises in the Reduction of the Blood Pressure in People With Resistant Hypertension

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension