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Title: | Safety and performance of the next generation EnligHTNTM renal denervation system in patients with drug-resistant, uncontrolled hypertension: The EnligHTN III first-in-human multicentre study. | Authors: | Antonis P.R.;Whitbourn R.J.;Warren R.J.;Worthley S.G.;Wilkins G.T.;Webster M.W.;Montarello J.K. | Institution: | (Worthley, Montarello) St Andrew's Hospital, Adelaide, Australia (Wilkins) Dunedin Hospital, Dunedin, New Zealand (Webster) Auckland City Hospital, Auckland, New Zealand (Antonis) Monash Heart, Monash Health, Melbourne, Australia (Whitbourn) St Vincent's Hospital, Melbourne, Australia (Warren) Royal Melbourne Hospital, Melbourne, Australia | Issue Date: | 10-Oct-2015 | Copyright year: | 2015 | Publisher: | Elsevier | Place of publication: | Netherlands | Publication information: | Clinical Trials and Regulatory Science in Cardiology. 8 (pp 4-10), 2015. Article Number: 10. Date of Publication: 01 Aug 2015. | Abstract: | Background/objectives Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the next generation EnligHTNTM renal denervation system. Six-month primary endpoint data are presented here. Methods We conducted this first-in-human, prospective, multi-center, non-randomized study in 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mm Hg) with drug-resistant hypertension. The primary safety and efficacy objectives were to characterize, from baseline to 6 months post-procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure. Results Renal artery denervation, using the next generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, and 6 months by - 19/7, - 26/9 and - 25/7 mm Hg, respectively (P <= 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through. Conclusions Renal sympathetic denervation using the next generation EnligHTN renal denervation system resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 6 months. Future studies will need to address the utility of this system against an appropriate placebo based comparator.Copyright © 2015 The Authors. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/j.ctrsc.2015.08.007 | ISSN: | 2405-5875 (electronic) | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/40875 | Type: | Article | Subjects: | heartburn/co [Complication] human hypertension/co [Complication] hypotension/co [Complication] *kidney denervation *kidney denervation system kidney function kidney pain/co [Complication] low back pain/co [Complication] male multicenter study nausea/co [Complication] practice guideline priority journal prospective study quality of life *resistant hypertension/dr [Drug Resistance] *resistant hypertension/dt [Drug Therapy] *resistant hypertension/th [Therapy] resistant hypertension/dt [Drug Therapy] skin bruising/co [Complication] systolic blood pressure vomiting/co [Complication] albumin/ec [Endogenous Compound] aldosterone antagonist/dt [Drug Therapy] alpha adrenergic receptor blocking agent/dt [Drug Therapy] angiotensin receptor antagonist/dt [Drug Therapy] beta adrenergic receptor blocking agent/dt [Drug Therapy] creatinine/ec [Endogenous Compound] cystatin C/ec [Endogenous Compound] dipeptidyl carboxypeptidase inhibitor/dt [Drug Therapy] *kidney denervation system/am [Adverse Device Effect] *kidney denervation system/ct [Clinical Trial] middle aged adult albumin blood level antihypertensive therapy application site bleeding/co [Complication] application site pain/co [Complication] article backache/co [Complication] blood pressure clinical article computer assisted tomography creatinine blood level *device safety female fever/co [Complication] flank pain/co [Complication] follow up glomerulus filtration rate headache/co [Complication] clinical article computer assisted tomography creatinine blood level *device safety adult fever / complication flank pain / complication follow up glomerulus filtration rate headache / complication heartburn / complication human hypertension / complication hypotension / complication *kidney denervation *kidney denervation system kidney function kidney pain / complication low back pain / complication male middle aged multicenter study nausea / complication practice guideline priority journal prospective study quality of life *resistant hypertension / *drug resistance / *drug therapy / *therapy resistant hypertension / drug therapy skin bruising / complication systolic blood pressure vomiting / complication female albumin blood level antihypertensive therapy application site bleeding / complication application site pain / complication Article backache / complication blood pressure |
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