EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2015
Symplicity multi-electrode radiofrequency renal denervation system feasibility study.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Whitbourn Robert, Harding Scott A, Walton Antony
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAntihypertensive AgentsAustraliaAutonomic DenervationBlood PressureBlood Pressure Monitoring, AmbulatoryCatheter AblationElectrodesEquipment DesignFeasibility StudiesFemaleHumansHypertensionKidneyMaleMiddle AgedNew ZealandOperative TimeProspective StudiesRenal ArteryTime FactorsTreatment Outcome