Key result
The Symplicity multi-electrode radiofrequency renal denervation system significantly reduced office systolic blood pressure by 19.2 mmHg at 12 months (P<0.001).
Why the study?
Does the Symplicity multi-electrode radiofrequency renal denervation system reduce systolic blood pressure in subjects with hypertension?
Does the Symplicity multi-electrode radiofrequency renal denervation system reduce systolic blood pressure in subjects with hypertension?
The Symplicity multi-electrode radiofrequency renal denervation system is feasible, safe, and significantly reduces systolic blood pressure at 12 months while reducing procedure time.
Should not change practice; leaves open efficacy of multi-electrode renal denervation in randomized trials.
AIMS: 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. METHODS AND 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. TRIAL REGISTRATION: NCT01699529.
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Whitbourn et al. (2015) studied hypertension (n=50). Symplicity multi-electrode radiofrequency renal denervation system was evaluated on 12-month change in office systolic blood pressure (SBP) (p=<0.001). The Symplicity multi-electrode radiofrequency renal denervation system significantly reduced office systolic blood pressure by 19.2 mmHg at 12 months (P<0.001).
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