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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Symplicity Spyral Renal Denervation System
DeviceSymplicity Renal Denervation
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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-procedureSecondary outcomes
1
Changes in office blood pressure
Time frame
1, 3, 6, 12, 24 and 36 months post-procedure2
Changes in home blood pressure
Time frame
1, 3, 6, 12, 24 and 36 months post-procedure3
Changes in 24-hour ambulatory blood pressure
Time frame
1, 3, 6, 12, 24 and 36 months post-procedure4
Changes of Number of medications
Time frame
1, 3, 6, 12, 24 and 36 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov