Global SYMPLICITY Registry
Research type
Research Study
Full title
GSR DEFINE
IRAS ID
263202
Contact name
Piers C Clifford
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 0 months, 1 days
Research summary
The purpose of this study is to collect data about the long-term safety and effectiveness of renal denervation in a real world patient population with high blood pressure and other diseases characterized by elevated sympathetic drive (such as diabetes mellitus type 2, renal insufficiency, etc). Approximately 3000 patients are to take part in this study using the Medtronic Symplicity Spyral™ Multi-electrode Renal Denervation Catheter (Symplicity Spyral catheter) and the Symplicity G3™ Renal Denervation Radiofrequency Generator (Symplicity G3 generator). This registry will prospectively collect data 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.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0344
Date of REC Opinion
29 Nov 2019
REC opinion
Further Information Favourable Opinion