Resistant Hypertension
Conditions
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.
Interventions
DEVICESymplicity Spyral Renal Denervation System
Symplicity Renal Denervation
Sponsors
Medtronic Vascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes in office blood pressure | 1, 3, 6, 12, 24 and 36 months post-procedure |
| Changes of Medication burden | 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 in home blood pressure | 1, 3, 6, 12, 24 and 36 months post-procedure |
Countries
China
Outcome results
None listed