Global SYMPLICITY Registry (GSR) DEFINE
Recruiting · NCT01534299 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medtronic Vascular
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years or minimum age as required by local regulations
- The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
- The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")
Where it is running
2 locations listed.
- Universitätsklinikum des Saarlandes - Homburg, Saarlandes, Germany
- Universitätsspital Basel - Basel, Switzerland, Switzerland