NCT01534299Recruiting
Global SYMPLICITY Registry (GSR) DEFINE
Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 13 Feb 2012
- Start date
- 1 Feb 2012
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Medtronic Vascular
- Diseases
- High blood pressure
- NCT number
- NCT01534299
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Feb 2012 to the primary completion date, 30 Jun 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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")
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Universitätsklinikum des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.