Global SYMPLICITY Registry (GSR) DEFINE
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01534299|
Recruitment Status : Recruiting
First Posted : February 16, 2012
Last Update Posted : August 5, 2021
|Condition or disease||Intervention/treatment|
|Hypertension||Device: Medtronic Renal Denervation System|
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|
|Estimated Enrollment :||5000 participants|
|Official Title:||Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)|
|Actual Study Start Date :||February 2012|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||October 2027|
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.
- BP Measurements [ Time Frame: 6 months ]Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534299
|Contact: K. Wandreyfirstname.lastname@example.org|
|Universitätsklinikum des Saarlandes||Recruiting|
|Homburg, Saarlandes, Germany, D-66421|
|Contact: Michael Böhm, MD (+49) 6841-1623372 email@example.com|
|Contact: Felix Mahfoud, MD +49 6841 16 21346 firstname.lastname@example.org|
|Principal Investigator: Michael Böhm, MD|
|Principal Investigator:||Michael Böhm, Prof.||University Hospital, Saarland|
|Principal Investigator:||Giuseppe Mancia, Prof.||San Gerardo Hospital, Monza, Italy|