Global SYMPLICITY Registry (GSR) DEFINE

Last updated: April 14, 2025
Sponsor: Medtronic Vascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Vascular Diseases

Stress

Treatment

Medtronic Renal Denervation System

Clinical Study ID

NCT01534299
10031728DOC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Medtronic Renal Denervation System
Phase:
Study Start date:
February 01, 2012
Estimated Completion Date:
December 31, 2031

Study 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")

Connect with a study center

  • Universitätsklinikum des Saarlandes

    Homburg, Saarlandes D-66421
    Germany

    Active - Recruiting

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, Saarlandes D-66421
    Germany

    Site Not Available

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

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