Symplicity China Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Symplicity Spyral Renal Denervation System.
- Who it may be relevant to
- Registry conditions: Resistant Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Device Symplicity Spyral Renal Denervation System
Symplicity Renal Denervation
Primary outcome measures
- 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 outcome measures (7)
- Changes in office blood pressure [Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure]
- Changes in home blood pressure [Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure]
- Changes in 24-hour ambulatory blood pressure [Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure]
- Changes of Number of medications [Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure]
- Changes of Medication burden [Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure]
- 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]
- Event rates [Time frame: 1, 3, 6, 12, 24 and 36 months post-procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhongshan Hospital Fudan University — Shanghai
Identifiers
NCT: NCT07081243 · MDT24050