Global SYMPLICITY Registry
|Hypertension Diabetes Mellitus Heart Failure Chronic Kidney Disease Sleep Apnea||Device: Medtronic Renal Denervation System|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry|
- BP Measurements [ Time Frame: 6 months ]Blood pressure changes from baseline (Office Setting and 24-hr Ambulatory measurements)
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||April 2021|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
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.
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 and individual disease state(s) characterized by elevated sympathetic drive.
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")
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534299
|Contact: K. Wandreyemail@example.com|
|Universitätsklinikum des Saarlandes||Recruiting|
|Homburg/Saar, Saarlandes, Germany, D-66421|
|Contact: Michael Böhm, MD (+49) 6841-1623372 firstname.lastname@example.org|
|Contact: Felix Mahfoud, MD +49 6841 16 21346 email@example.com|
|Principal Investigator: Michael Böhm, MD|
|Principal Investigator:||Michael Böhm, Prof.||University Hospital, Saarland|
|Principal Investigator:||Giuseppe Mancia, Prof.||San Gerardo Hospital, Monza, Italy|