Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.
Conditions studied
Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
About this study
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.
Interventions
- Device: Symplicity Spyral™ multi-electrode renal denervation system — After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Primary outcomes
- Procedure time (Procedure)
- Office Systolic Blood Pressure Change (6 months)
Eligibility information
Study locations
- The Alfred Hospital, Melbourne, Australia
- Royal Perth Hospital, Perth, Australia
- Ziekenhuis Oost Limburg, Genk, Limburg 3600 Belgium
- CHC MontLégia, Liège, Liège 4000 Belgium
- Algemeen Stedelijk Ziekenhuis - Campus Aalst, Aalst, Belgium
- AZ Sint Jan Brugge-Oostende av, Bruges, 8000 Belgium
- Universitair Ziekenhuis Gent, Ghent, 9000 Belgium
- Universitat des Saarlandes, Homburg, Saarland 66123 Germany
- Sana Kliniken Lübeck GmbH, Lübeck, Schleswig-Holstein 23560 Germany
- Universitätsklinikum Erlangen, Erlangen, Germany
Showing 10 of 21 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-04.