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RECRUITING
NCT07115953
NA

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension

Sponsor: Medtronic Vascular

View on ClinicalTrials.gov

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

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.

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