Global SYMPLICITY Registry (GSR) DEFINE
ConditionHypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Vascular
About this trial
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
This trial does not accept healthy volunteersQualifiers
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")
Disqualifiers
None
Trial population
Subjects undergoing renal denervation procedure for hypertension
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Medtronic Renal Denervation System
DeviceThe 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.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Renal Denervation Treatment1 intervention
Trial outcomes
Primary outcomes
1
BP Measurements
Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov