Follows people with high blood pressure after kidney nerve treatment
Tracks long-term safety of a device that treats kidney nerves in adults with hypertension.
Key facts
- Who runs it
- Medtronic Vascular
- Where
- Basel, SwitzerlandSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Global SYMPLICITY Registry (GSR) DEFINE
- Status
- Recruiting
- People taking part
- 5,000 people, planned
- Started
- Feb 2012
- Expected to end
- Dec 2031
- Type of study
- Observational
- Treatments tested
- Medtronic Renal Denervation System
- Record updated
- 23 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The registry is looking for adults with high blood pressure who are having the renal denervation procedure with the Medtronic system. They are followed for 1 to 5 years.
- Age
- 18 years or older, or the minimum age required by local rules
- Sex
- All sexes can join
- Disease stage
- Uncontrolled high blood pressure (hypertension)
- Earlier treatment
- The procedure must be done with a new, market-released Medtronic renal denervation catheter.
Main reasons for not taking part
- Not an acceptable candidate for renal denervation under the Medtronic Instructions For Use
- No signed consent form from the patient or legal representative
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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 in Switzerland
Also in 1 other country, 1 site
- Universitätsspital BaselBasel, SwitzerlandContact: Felix Mahfoud, Prof. Dr.Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Renal Denervation Treatment
All patients treated with renal denervation procedure will be enrolled as part of this single arm registry
Treatment: Medtronic Renal Denervation System
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
- Plain-language title
- Follows people with high blood pressure after kidney nerve treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Sex stratified analysis of patients with resistant hypertension from the Global SYMPLICITY Registry of renal denervation.Hypertension research : official journal of the Japanese Society of Hypertension, 2026
- Record updated
- 23 October 2026