title: Symplicity multi-electrode radiofrequency renal denervation system feasibility study.
abstract: OBJECTIVE
  The aim of this study was to test the safety and performance of the Symplicity™ multi-electrode radio-frequency renal denervation system which was designed to reduce procedure time during renal denervation.
  
  
  RESULTS
  The multi-electrode radiofrequency renal denervation system feasibility study is a prospective, non-randomised, open label, feasibility study that enrolled 50 subjects with hypertension. The study utilises a new renal denervation catheter which contains an array of four electrodes mounted in a helical configuration at 90 degrees from each other to deliver radiofrequency energy simultaneously to all four renal artery quadrants for 60 seconds. The protocol specified one renal denervation treatment towards the distal end of each main renal artery with radiofrequency energy delivered for 60 seconds per treatment. Total treatment time for both renal arteries was two minutes. The 12-month change in office systolic blood pressure (SBP) and 24-hour SBP was -19.2±25.2 mmHg, p<0.001, and -7.6±20.0 mmHg, p=0.020, respectively. There were three patients with access-site complications, none of which was related to energy delivery; all were treated successfully. No new renal artery stenosis or hypertensive emergencies occurred.
  
  
  CONCLUSIONS
  The Symplicity multi-electrode radiofrequency renal denervation system was associated with a significant reduction in SBP at 12 months and minimal complications whilst it also reduced procedure time.
  
  
  BACKGROUND
  NCT01699529.
authors.affiliation: St. Vincent's Hospital, Melbourne, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Scott A
authors.initials: SA
authors.lastname: Harding
authors.forename: Antony
authors.initials: A
authors.lastname: Walton
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001315:Australia; D017763:Autonomic Denervation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D001794:Blood Pressure / Q000187:drug effects; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D004566:Electrodes; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D007668:Kidney / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D061646:Operative Time; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents