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Observational Study
. 2024 Oct;113(10):1375-1383.
doi: 10.1007/s00392-023-02325-x. Epub 2023 Nov 9.

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design

Felix Mahfoud  1   2 , Michel Azizi  3   4   5 , Joost Daemen  6 , Andrew S P Sharp  7 , Atul Patak  8 , Juan F Iglesias  9 , Ajay Kirtane  10 , Naomi D L Fisher  11 , Andrea Scicli  12 , Melvin D Lobo  13
Affiliations
Observational Study

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design

Felix Mahfoud et al. Clin Res Cardiol. 2024 Oct.

Abstract

Background: Hypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension. The multicenter, single-arm, observational Global Paradise™ System (GPS) registry has been designed to examine the long-term safety and effectiveness of ultrasound RDN (uRDN) with the Paradise System in a large population of patients with hypertension.

Methods: The study aims to enroll up to 3000 patients undergoing uRDN in routine clinical practice. Patients will be recruited over a 4-year period and followed for 5 years (at 3, 6, and 12 months after the uRDN procedure and annually thereafter). Standardized home BP measurements will be taken every 3 months with automatic upload to the cloud. Office and ambulatory BP and adverse events will be collected as per routine clinical practice. Quality-of-Life questionnaires will be used to capture patient-reported outcomes.

Conclusions: This observational registry will provide real-world information on the safety and effectiveness of uRDN in a large population of patients treated during routine clinical practice, and also allow for a better understanding of responses in prespecified subgroups. The focus on home BP in this registry is expected to improve completeness of long-term follow-up and provide unique insights into BP over time.

Keywords: Home blood pressure; Hypertension; Patient-reported outcomes; Registry; Renal denervation; Ultrasound.

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Conflict of interest statement

FM is supported by Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Forschungsgemeinschaft (SFB TRR219, Project-ID 322900939), and Deutsche Herzstiftung. He has received scientific support from Ablative Solutions, Medtronic and Recor Medical and speaker honoraria/consulting fees from Ablative Solutions, Amgen, Astra-Zeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, Recor Medical, Servier, and Terumo. MA has received research grants from the European Horizon 2020 program; has received grant support and nonfinancial support from Recor Medical, Idorsia, Novartis; and has received personal fees from Alnylam Pharmaceuticals, Cincor, Medtronic, Astra-Zeneca, and Novartis. JD has received institutional grant/research support from Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, Microport, Pie Medical, and Recor Medical, and consultancy and speaker fees from Abbott Vascular, Abiomed, ACIST Medical, Boston Scientific, Cardialysis BV, CardiacBooster, Kaminari Medical, Recor Medical, PulseCath, Pie Medical, Sanofi, Siemens Health Care and Medtronic. ASharp has received personal fees from Recor Medical, Medtronic, Boston Scientific, Penumbra and Philips. AP has received institutional grant/research support, consultancy/speaker fees and travel grants from Recor Medical, Medtronic, and Ablative Solutions. JFI has received research grants to the institution from Abbott Vascular, Astra Zeneca, Biosensors International, Biotronik, Concept Medical, Philips Volcano, and Terumo Corp.; honoraria/speaker’s fees from Astra Zeneca, Biosensors International, Biotronik, Bristol Myers Squibb/Pfizer, Cordis, Concept Medical, Medalliance, Medtronic, Novartis, Philips Volcano, and Terumo Corp.; and is consultant for Biotronik, Cordis, Medtronic, Recor Medical, and Terumo Corp. AK reports Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, Recor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting. Personal: Consulting: Neurotronic; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, Recor Medical, Chiesi, OpSens, Zoll, and Regeneron. NF has received grant support and personal fees from Recor Medical, and personal fees from Medtronic. AScicli is an employee of Recor Medical. MLB is a consultant to Medtronic, Recor Medical, Ablative Solutions and Vascular Dynamics and has received educational grant funding from Medtronic and Recor Medical.

Figures

Fig. 1
Fig. 1
Paradise ultrasound renal denervation system
See this image and copyright information in PMC

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