Global SYMPLICITY Registry (GSR) DEFINE

April 22, 2026 updated by: Medtronic Vascular

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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")

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Saarlandes
      • Homburg, Saarlandes, Germany, D-66421
        • Recruiting
        • Universitatsklinikum des Saarlandes
        • Contact:
        • Principal Investigator:
          • Michael Böhm, MD
  • Switzerland
    • Switzerland
      • Basel, Switzerland, Switzerland, 4031
        • Recruiting
        • Universitätsspital Basel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing renal denervation procedure for hypertension

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal Denervation Treatment
All patients treated with renal denervation procedure will be enrolled as part of this single arm registry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BP Measurements
Time Frame: 6 months
Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Vascular

Investigators

  • Principal Investigator: Michael Böhm, Prof., University Hospital, Saarland
  • Principal Investigator: Giuseppe Mancia, Prof., San Gerardo Hospital, Monza, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimated)

February 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10031728DOC

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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