Symplicity China Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-11

Study Completion Date

2031-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Resistant Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Symplicity Spyral Renal Denervation System

Symplicity Renal Denervation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No