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Studies

Interventional Recruiting

NCT07115953 on ClinicalTrials.gov

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

Official title: Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)

  • Sponsor: Medtronic (Group)
  • Enrollment: 130 (Estimated)
  • Study start: 2025-09-22 (Actual)
  • Primary completion: 2027-10-30 (Estimated)
  • Study completion: 2030-04-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • Chronic Kidney Diseases
  • Diabetes Mellitus

Intervention / Treatment

  • Device: Symplicity Spyralâ„¢ multi-electrode renal denervation system

Primary Outcome Measures

  • Procedure time (Procedure)
    Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.
  • Office Systolic Blood Pressure Change (6 months)
    Office Systolic Blood Pressure (OSBP) change from baseline to 6 months will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED study efficacy endpoints using a propensity score stratified baseline blood pressure adjusted analysis at 3 months (OFF MED) and 6 months (ON MED).

Countries

Australia, Belgium, Germany, Greece, Ireland, Malaysia, Netherlands, Taiwan, United Kingdom

Locations and Investigators

  • The Alfred Hospital, Melbourne, Australia (Recruiting)
    • Tony Walton, MD
    • Tony Walton, MD (Principal Investigator)
  • Royal Perth Hospital, Perth, Australia (Recruiting)
    • Markus Schlaich, MD
    • Markus Schlaich, MD (Principal Investigator)
  • Ziekenhuis Oost Limburg, Genk, Belgium (Recruiting)
    • Koen Ameloot, MD
    • Koen Ameloot, MD (Principal Investigator)
  • CHC MontLégia, Liège, Belgium (Recruiting)
    • Pieter-Jan Palmers, MD
    • Pieter-Jan Palmers, MD (Principal Investigator)
  • Algemeen Stedelijk Ziekenhuis - Campus Aalst, Aalst, Belgium (Recruiting)
    • Jan Debrauwere, MD
    • Jan Debrauwere, MD (Principal Investigator)
  • AZ Sint Jan Brugge-Oostende av, Bruges, Belgium (Recruiting)
    • Jan Van Der Hyden, MD
    • Jan Van Der Hyden, MD (Principal Investigator)
  • Universitair Ziekenhuis Gent, Ghent, Belgium (Recruiting)
    • Benny Drieghe, MD
    • Benny Drieghe, MD (Principal Investigator)
  • Universitat des Saarlandes, Homburg, Germany (Recruiting)
    • Bakuradze Tamara
    • Michael Böhm, MD (Principal Investigator)
  • Sana Kliniken Lübeck GmbH, Lübeck, Germany (Recruiting)
    • Joachim Weil, MD
    • Tolga Agdirlioglu, MD
    • Joachim Weil, MD (Principal Investigator)
  • Universitätsklinikum Erlangen, Erlangen, Germany (Recruiting)
    • Roland Schmeider, MD
    • Roland Schmeider, MD (Principal Investigator)
  • Leipzig Heart Institute, Leipzig, Germany (Recruiting)
    • Karl Fengler, MD
    • Karl Fenger, MD (Principal Investigator)
  • Schwarzwald-Baar Klinikum Villingen-Schwenningen, Villingen-Schwenningen, Germany (Recruiting)
    • Sebastian Ewen, Prof. Dr.
    • Sebastian Ewen, Prof. Dr. (Principal Investigator)
  • Hippokration General Hospital of Athens, Athens, Greece (Recruiting)
    • Fotis Tatakis
    • Konstantinos Tsioufis, Prof Dr (Principal Investigator)
  • Mater Misericordiae University Hospital, Dublin, Ireland (Terminated)
  • Sarawak Heart Center, Kota, Malaysia (Recruiting)
    • Ong Tiong Kiam, MD
    • Ong Tiong Kiam (Principal Investigator)
  • Institut Jantung Negara - National Heart Institute, Kuala Lumpur, Malaysia (Recruiting)
    • Renobastian Nur Syamsi
    • Amin Ariff Nuruddin, Dr (Principal Investigator)
  • Zuyderland Medisch Centrum Heerlen, Heerlen, Netherlands (Recruiting)
    • Saman Rasoul, MD
    • Saman Rasoul, MD (Principal Investigator)
  • Erasmus University Medical Center, Rotterdam, Netherlands (Recruiting)
    • Joost Daemen, MD, PhD
    • Joost Daemen, MD, PhD (Principal Investigator)
  • MacKay Memorial Hospital, Tamsui Branch, Taipei, Taiwan (Recruiting)
    • Ying-Hsiang Lee, Dr.
    • Yuping (Alice) Huang
    • Ying-Hsiang Lee, Dr. (Principal Investigator)
  • National Taiwan University Hospital, Taipei, Taiwan (Recruiting)
    • Tzung-Dau Wang, Prof. Dr.
    • Yachun Chen
    • Tzung-Dau Wang, Prof. Dr. (Principal Investigator)
  • Oxford University Hospitals NHS Trust - John Radcliffe Hospital, Oxford, United Kingdom (Recruiting)
    • Giovanni Luigi De Maria, MD
    • Giovanni Luigi De Maria (Principal Investigator)

Study Officials