HypertensionNCT01534299
Global SYMPLICITY Registry (GSR) DEFINE
An observational study of Hypertension, run by Medtronic Vascular at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Medtronic Renal Denervation System
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2012to Dec 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing renal denervation procedure for hypertension
Who may be able to join
- 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")
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
K. Wandrey contact
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum des Saarlandes
Homburg, Saarlandes, D-66421
Michael Böhm, MD, (+49) 6841-1623372, michael.boehm@uniklinikum-saarland.de
Michael Böhm, MD
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Basel
Basel, Switzerland, 4031
Felix Mahfoud, Prof. Dr., felix.mahfoud@usb.ch
About this study
Official title: Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
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.
Read the detailed description
This registry will collect data prospectively on patients that receive renal denervation and treatment will be applied according to the 'Intended Use' in the IFU. The treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. This registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the Medtronic renal denervation system in a real world patient population.
The key measures collected for the patients will be inclusive of, but are not limited to, blood pressure measurements, change in medications, eGFR changes (based on the MDRD formula) and clinical data pertaining to hypertension .
The inclusion criteria for the registry includes:
- 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")
- Conditions
- Hypertension
- Being tested
- Medtronic Renal Denervation System
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Renal Denervation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation Treatment | All patients treated with renal denervation procedure will be enrolled as part of this single arm registry Receives: Device: Medtronic Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP Measurements
Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Böhm, Prof., Principal investigator, University Hospital, SaarlandGiuseppe Mancia, Prof., Principal investigator, San Gerardo Hospital, Monza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534299
- Sponsor's protocol ID
- 10031728DOC
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2012
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Nolde JM, Kiuchi MG, Carnagarin R, Ward NC, Wanten M, Bohm M, Mahfoud F, Schmieder RE, Narkiewicz K, Schlaich MP. Impact of centrally acting sympatholytic agents on the blood pressure response to renal denervation. J Hypertens. 2026 Apr 1;44(4):592-599. doi: 10.1097/HJH.0000000000004219. Epub 2025 Dec 10.
PubMed 41411629Mihailidou AS, Mahfoud F, Schlaich M, Schmieder R, Narkiewicz K, Ruilope L, Fahy M, Bohm M, Mancia G, Nickel L, Hettrick DA, Weil J. Sex stratified analysis of patients with resistant hypertension from the Global SYMPLICITY Registry of renal denervation. Hypertens Res. 2026 Mar;49(3):904-915. doi: 10.1038/s41440-025-02446-y. Epub 2025 Nov 20.
PubMed 41266871Schlaich MP, Mahfoud F, Bohm M, Narkiewicz K, Ruilope L, Williams B, Mancia G, Sharif F, Ribichini F, Lung TH, Shetty S, Schmieder RE. Renal Denervation in Patients With Moderate to Severe Chronic Kidney Disease. Hypertension. 2025 Dec;82(12):2252-2261. doi: 10.1161/HYPERTENSIONAHA.125.25470. Epub 2025 Oct 29.
PubMed 41159269Mahfoud F, Mancia G, Schmieder RE, Ruilope L, Narkiewicz K, Schlaich M, Williams B, Ribichini F, Weil J, Almerri K, Sharif F, Lauder L, Wanten M, Fahy M, Bohm M. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug;80(8):1759-1770. doi: 10.1161/HYPERTENSIONAHA.123.21283. Epub 2023 Jun 15.
PubMed 37317866Mahfoud F, Mancia G, Schmieder RE, Ruilope L, Narkiewicz K, Schlaich M, Williams B, Ribichini F, Weil J, Kao HL, Rodriguez-Leor O, Noory E, Ong TK, Unterseeh T, de Araujo Goncalves P, Zirlik A, Almerri K, Sharif F, Lauder L, Wanten M, Fahy M, Bohm M. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. J Am Coll Cardiol. 2022 Nov 15;80(20):1871-1880. doi: 10.1016/j.jacc.2022.08.802.
PubMed 36357087Mahfoud F, Mancia G, Schmieder R, Narkiewicz K, Ruilope L, Schlaich M, Whitbourn R, Zirlik A, Zeller T, Stawowy P, Cohen SA, Fahy M, Bohm M. Renal Denervation in High-Risk Patients With Hypertension. J Am Coll Cardiol. 2020 Jun 16;75(23):2879-2888. doi: 10.1016/j.jacc.2020.04.036.
PubMed 32527396Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M, Kandzari D, Kario K, Mancia G, Weber M, Bohm M. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100. doi: 10.1093/eurheartj/ehw325.
PubMed 28158510Linz D, Mancia G, Mahfoud F, Narkiewicz K, Ruilope L, Schlaich M, Kindermann I, Schmieder RE, Ewen S, Williams B, Bohm M; Global SYMPLICITY Registry Investigators. Renal artery denervation for treatment of patients with self-reported obstructive sleep apnea and resistant hypertension: results from the Global SYMPLICITY Registry. J Hypertens. 2017 Jan;35(1):148-153. doi: 10.1097/HJH.0000000000001142.
PubMed 27906840Kim BK, Bohm M, Mahfoud F, Mancia G, Park S, Hong MK, Kim HS, Park SJ, Park CG, Seung KB, Gwon HC, Choi DJ, Ahn TH, Kim CJ, Kwon HM, Esler M, Jang YS. Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea). J Hum Hypertens. 2016 May;30(5):315-21. doi: 10.1038/jhh.2015.77. Epub 2015 Jul 9.
PubMed 26155994Bohm M, Mahfoud F, Ukena C, Hoppe UC, Narkiewicz K, Negoita M, Ruilope L, Schlaich MP, Schmieder RE, Whitbourn R, Williams B, Zeymer U, Zirlik A, Mancia G; GSR Investigators. First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension. 2015 Apr;65(4):766-74. doi: 10.1161/HYPERTENSIONAHA.114.05010. Epub 2015 Feb 17.
PubMed 25691618