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

Mahfoud, Felix, Azizi, Michel, Daemen, Joost, Sharp, Andrew S.P., Patak, Atul, Iglesias, Juan F., Kirtane, Ajay, Fisher, Naomi D. L., Scicli, Andrea and Lobo, Melvin D. 2023. Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design. Clinical Research in Cardiology 10.1007/s00392-023-02325-x

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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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine
Publisher:	Springer
ISSN:	1861-0684
Date of First Compliant Deposit:	26 April 2024
Date of Acceptance:	13 October 2023
Last Modified:	26 Apr 2024 14:40
URI:	https://orca.cardiff.ac.uk/id/eprint/167950

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