Global SYMPLICITY Registry (GSR) DEFINE
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ClinicalTrials.gov Identifier: NCT01534299 |
Recruitment Status :
Recruiting
First Posted : February 16, 2012
Last Update Posted : October 20, 2022
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Condition or disease | Intervention/treatment |
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Hypertension | Device: Medtronic Renal Denervation System |
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")
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE) |
Actual Study Start Date : | February 2012 |
Estimated Primary Completion Date : | May 2024 |
Estimated Study Completion Date : | October 2027 |

Group/Cohort | Intervention/treatment |
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Renal Denervation Treatment
All patients treated with renal denervation procedure will be enrolled as part of this single arm registry
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Device: 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. |
- BP Measurements [ Time Frame: 6 months ]Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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")

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534299
Contact: K. Wandrey | rs.medtroniccardiovascularclinicaltrials@medtronic.com |
Germany | |
Universitätsklinikum des Saarlandes | Recruiting |
Homburg, Saarlandes, Germany, D-66421 | |
Contact: Michael Böhm, MD (+49) 6841-1623372 michael.boehm@uniklinikum-saarland.de | |
Contact: Felix Mahfoud, MD +49 6841 16 21346 felix.mahfoud@uniklinikum-saarland.de | |
Principal Investigator: Michael Böhm, MD |
Principal Investigator: | Michael Böhm, Prof. | University Hospital, Saarland | |
Principal Investigator: | Giuseppe Mancia, Prof. | San Gerardo Hospital, Monza, Italy |
Responsible Party: | Medtronic Vascular |
ClinicalTrials.gov Identifier: | NCT01534299 |
Other Study ID Numbers: |
10031728DOC |
First Posted: | February 16, 2012 Key Record Dates |
Last Update Posted: | October 20, 2022 |
Last Verified: | October 2022 |
Hypertension Vascular Diseases Cardiovascular Diseases |