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Global SYMPLICITY Registry (GSR) DEFINE
Sponsor: Medtronic Vascular
Summary
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.
Official title: Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2012-02
Completion Date
2031-12
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Medtronic Renal Denervation System
The Symplicity renal denervation system is comprised of a single-use, disposable catheter and a reusable radiofrequency (RF) generator. The Symplicity renal denervation system has CE Marking for the intended use of delivering low-level radiofrequency energy through the wall of the renal artery to denervate the human kidney.
Locations (2)
Universitätsklinikum des Saarlandes
Homburg, Saarlandes, Germany
Universitätsspital Basel
Basel, Switzerland