Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2012-02-29
2031-12-31
Brief Summary
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Detailed Description
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The key measures collected for the patients will be inclusive of, but are not limited to, blood pressure measurements, change in medications, eGFR changes (based on the MDRD formula) and clinical data pertaining to hypertension .
The inclusion criteria for the registry includes:
* Age ≥ 18 years or minimum age as required by local regulations
* The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
* The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Renal Denervation Treatment
All patients treated with renal denervation procedure will be enrolled as part of this single arm registry
Medtronic Renal Denervation System
The Symplicity renal denervation system is comprised of a single-use, disposable catheter and a reusable radiofrequency (RF) generator. The Symplicity renal denervation system has CE Marking for the intended use of delivering low-level radiofrequency energy through the wall of the renal artery to denervate the human kidney.
Interventions
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Medtronic Renal Denervation System
The Symplicity renal denervation system is comprised of a single-use, disposable catheter and a reusable radiofrequency (RF) generator. The Symplicity renal denervation system has CE Marking for the intended use of delivering low-level radiofrequency energy through the wall of the renal artery to denervate the human kidney.
Eligibility Criteria
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Inclusion Criteria
* The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
* The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Böhm, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Saarland
Giuseppe Mancia, Prof.
Role: PRINCIPAL_INVESTIGATOR
San Gerardo Hospital, Monza, Italy
Locations
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Universitätsklinikum des Saarlandes
Homburg, Saarlandes, Germany
Universitätsspital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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MD
Role: backup
References
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Schlaich MP, Mahfoud F, Bohm M, Narkiewicz K, Ruilope L, Williams B, Mancia G, Sharif F, Ribichini F, Lung TH, Shetty S, Schmieder RE. Renal Denervation in Patients With Moderate to Severe Chronic Kidney Disease. Hypertension. 2025 Oct 29. doi: 10.1161/HYPERTENSIONAHA.125.25470. Online ahead of print.
Mahfoud F, Mancia G, Schmieder RE, Ruilope L, Narkiewicz K, Schlaich M, Williams B, Ribichini F, Weil J, Almerri K, Sharif F, Lauder L, Wanten M, Fahy M, Bohm M. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug;80(8):1759-1770. doi: 10.1161/HYPERTENSIONAHA.123.21283. Epub 2023 Jun 15.
Mahfoud F, Mancia G, Schmieder RE, Ruilope L, Narkiewicz K, Schlaich M, Williams B, Ribichini F, Weil J, Kao HL, Rodriguez-Leor O, Noory E, Ong TK, Unterseeh T, de Araujo Goncalves P, Zirlik A, Almerri K, Sharif F, Lauder L, Wanten M, Fahy M, Bohm M. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. J Am Coll Cardiol. 2022 Nov 15;80(20):1871-1880. doi: 10.1016/j.jacc.2022.08.802.
Mahfoud F, Mancia G, Schmieder R, Narkiewicz K, Ruilope L, Schlaich M, Whitbourn R, Zirlik A, Zeller T, Stawowy P, Cohen SA, Fahy M, Bohm M. Renal Denervation in High-Risk Patients With Hypertension. J Am Coll Cardiol. 2020 Jun 16;75(23):2879-2888. doi: 10.1016/j.jacc.2020.04.036.
Mahfoud F, Bakris G, Bhatt DL, Esler M, Ewen S, Fahy M, Kandzari D, Kario K, Mancia G, Weber M, Bohm M. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017 Jan 7;38(2):93-100. doi: 10.1093/eurheartj/ehw325.
Linz D, Mancia G, Mahfoud F, Narkiewicz K, Ruilope L, Schlaich M, Kindermann I, Schmieder RE, Ewen S, Williams B, Bohm M; Global SYMPLICITY Registry Investigators. Renal artery denervation for treatment of patients with self-reported obstructive sleep apnea and resistant hypertension: results from the Global SYMPLICITY Registry. J Hypertens. 2017 Jan;35(1):148-153. doi: 10.1097/HJH.0000000000001142.
Kim BK, Bohm M, Mahfoud F, Mancia G, Park S, Hong MK, Kim HS, Park SJ, Park CG, Seung KB, Gwon HC, Choi DJ, Ahn TH, Kim CJ, Kwon HM, Esler M, Jang YS. Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea). J Hum Hypertens. 2016 May;30(5):315-21. doi: 10.1038/jhh.2015.77. Epub 2015 Jul 9.
Bohm M, Mahfoud F, Ukena C, Hoppe UC, Narkiewicz K, Negoita M, Ruilope L, Schlaich MP, Schmieder RE, Whitbourn R, Williams B, Zeymer U, Zirlik A, Mancia G; GSR Investigators. First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension. 2015 Apr;65(4):766-74. doi: 10.1161/HYPERTENSIONAHA.114.05010. Epub 2015 Feb 17.
Other Identifiers
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10031728DOC
Identifier Type: -
Identifier Source: org_study_id
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