Symplicity China Study
ConditionResistant Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Vascular
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Symplicity Spyral Renal Denervation System
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov