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RecruitingNCT01534299

Global SYMPLICITY Registry (GSR) DEFINE

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

Sponsor

Medtronic Vascular

Enrollment

5,000 participants

Start Date

Feb 1, 2012

Study Type

OBSERVATIONAL

Conditions

Hypertension

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a global registry study following patients who undergo renal denervation — a minimally invasive procedure that uses a special catheter to reduce nerve activity in the arteries around the kidneys, primarily to help control resistant high blood pressure. **You may be eligible if...** - You are 18 years or older (or meet your country's minimum age requirement) - Your doctor has determined you are a suitable candidate for the renal denervation procedure using the Medtronic system - You or your legal representative has consented to participate and share your data **You may NOT be eligible if...** - You do not qualify for the renal denervation procedure based on the device instructions - You refuse to give consent or share your medical information - You are below the minimum age required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(2)

Universitätsklinikum des Saarlandes

Homburg, Saarlandes, Germany

Universitätsspital Basel

Basel, Switzerland, Switzerland

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NCT01534299

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