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Global SYMPLICITY Registry (GSR) DEFINE

Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01534299
Enrollment
5000
Registered
2012-02-16
Start date
2012-02-01
Completion date
2031-12-01
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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 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.

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")

Interventions

DEVICEMedtronic 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.

Sponsors

Medtronic Vascular
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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")

Design outcomes

Primary

MeasureTime frameDescription
BP Measurements6 monthsBlood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)

Countries

Germany, Switzerland

Contacts

CONTACTK. Wandrey
rs.medtroniccardiovascularclinicaltrials@medtronic.com
PRINCIPAL_INVESTIGATORMichael Böhm, Prof.

University Hospital, Saarland

PRINCIPAL_INVESTIGATORGiuseppe Mancia, Prof.

San Gerardo Hospital, Monza, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026