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NCT01534299 · ClinicalTrials.gov record · last posted 2026-04-27

Global SYMPLICITY Registry (GSR) DEFINE

StatusRecruiting
PhaseNot specified
Started2012-02
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from the ClinicalTrials.gov record
This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.

Amendment record 34 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 34 times since 2012-02-15; most recent amendment 2026-04-22. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT01534299
Lead Sponsor Medtronic Vascular
Conditions Hypertension
Enrollment 5,000 participants
Start Date 2012-02
Primary Completion 2027-06 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-27