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Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Sponsor: Medtronic Vascular
Summary
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.
Official title: Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-09-22
Completion Date
2029-12-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Symplicity Spyral™ multi-electrode renal denervation system
After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Locations (19)
The Alfred Hospital
Melbourne, Australia
Royal Perth Hospital
Perth, Australia
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, Limburg, Belgium
CHC MontLégia
Liège, Liège, Belgium
Algemeen Stedelijk Ziekenhuis - Campus Aalst
Aalst, Belgium
AZ Sint Jan Brugge-Oostende av
Bruges, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Universitat des Saarlandes
Homburg, Saarland, Germany
Sana Kliniken Lübeck GmbH
Lübeck, Schleswig-Holstein, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Leipzig Heart Institute
Leipzig, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Mater Misericordiae University Hospital
Dublin, Dublin, Ireland
Sarawak Heart Center
Kota, Malaysia
Zuyderland Medisch Centrum Heerlen
Heerlen, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
MacKay Memorial Hospital, Tamsui Branch
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
Oxford, United Kingdom