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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symplicity Spyral Renal Denervation System | Device | Symplicity Renal Denervation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 210000 | China |
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| 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 |
| Proportion of subjects achieving blood pressure reduction and control to ≤140 mmHg (measured by OBP, HBP, and ABPM) | 1, 3, 6, 12, 24 and 36 months post-procedure |
| Event rates | 1, 3, 6, 12, 24 and 36 months post-procedure |