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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension; Diabetes Mellitus; Chronic Kidney Diseases
• Intervention / Treatment: Device: Symplicity Spyral™ multi-electrode renal denervation system

Detailed Description

SPYRAL SWYFT will evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system to determine whether renal denervation 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 (where all accessible renal arterial vessels between 3 and 8 mm in diameter including accessory, branch and main renal arteries (outside the kidney parenchyma) were targeted for ablation).

SPYRAL SWYFT study is conducted under the overarching SPYRAL AFFIRM protocol (NCT05198674), focused on EU and APAC regions.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelsey Anderson; Phone Number: 651 247 5268; Email: rs.spyralaffirm@medtronic.com
• Study Contact Backup: Name: Carly Loudoun; Phone Number: +31 43 356 6566; Email: rs.spyralaffirm@medtronic.com

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • The Alfred Hospital
    • Contact: Tony Walton, MD
    • Principal Investigator: Tony Walton, MD
  • Perth, Australia
    • Recruiting
    • Royal Perth Hospital
    • Principal Investigator: Markus Schlaich, MD
    • Contact: Markus Schlaich, MD
• Belgium
  • Aalst, Belgium
    • Recruiting
    • Algemeen Stedelijk Ziekenhuis - Campus Aalst
    • Principal Investigator: Jan Debrauwere, MD
    • Contact: Jan Debrauwere, MD
  • Bruges, Belgium, 8000
    • Recruiting
    • AZ Sint Jan Brugge-Oostende av
    • Contact: Jan Van Der Hyden, MD
    • Principal Investigator: Jan Van Der Hyden, MD
  • Ghent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
    • Contact: Benny Drieghe, MD
    • Principal Investigator: Benny Drieghe, MD
  • Liège, Belgium, 4000
    • Recruiting
    • CHC MontLegia
    • Contact: Pieter-Jan Palmers, MD
    • Principal Investigator: Pieter-Jan Palmers, MD
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost Limburg
      • Contact: Koen Ameloot, MD
      • Principal Investigator: Koen Ameloot, MD
• Germany
  • Erlangen, Germany
    • Recruiting
    • Universitätsklinikum Erlangen
    • Contact: Roland Schmeider, MD
    • Principal Investigator: Roland Schmeider, MD
  • Leipzig, Germany
    • Recruiting
    • Leipzig Heart Institute
    • Contact: Karl Fengler, MD
    • Principal Investigator: Karl Fenger, MD
  • Villingen-Schwenningen, Germany
    • Recruiting
    • Schwarzwald-Baar Klinikum Villingen-Schwenningen
    • Contact: Sebastian Ewen, Prof. Dr.
    • Principal Investigator: Sebastian Ewen, Prof. Dr.
  • Saarland
    • Homburg, Saarland, Germany, 66123
      • Recruiting
      • Universität des Saarlandes
      • Principal Investigator: Michael Böhm, MD
      • Contact: Bakuradze Tamara
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23560
      • Recruiting
      • Sana Kliniken Lübeck GmbH
      • Principal Investigator: Joachim Weil, MD
      • Contact: Joachim Weil, MD
      • Contact: Tolga Agdirlioglu, MD
• Ireland
  • Dublin, Ireland, D07 R2WY
    • Terminated
    • Mater Misericordiae University Hospital
• Malaysia
  • Kota, Malaysia
    • Recruiting
    • Sarawak Heart Center
    • Contact: Ong Tiong Kiam, MD
    • Principal Investigator: Ong Tiong Kiam
• Netherlands
  • Heerlen, Netherlands, 6419 PC
    • Recruiting
    • Zuyderland Medisch Centrum Heerlen
    • Contact: Saman Rasoul, MD
    • Principal Investigator: Saman Rasoul, MD
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus University Medical Center
    • Contact: Joost Daemen, MD, PhD; Phone Number: +31 10 70 393 07; Email: j.daemen@erasmusmc.nl
    • Principal Investigator: Joost Daemen, MD, PhD
• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Tzung-Dau Wang, Prof. Dr.
    • Contact: Yachun Chen
    • Principal Investigator: Tzung-Dau Wang, Prof. Dr.
  • Taipei, Taiwan
    • Recruiting
    • MacKay Memorial Hospital, Tamsui Branch
    • Contact: Ying-Hsiang Lee, Dr.
    • Contact: Yuping (Alice) Huang
    • Principal Investigator: Ying-Hsiang Lee, Dr.
• United Kingdom
  • Oxford, United Kingdom
    • Recruiting
    • Oxford University Hospitals NHS Trust - John Radcliffe Hospital
    • Principal Investigator: Giovanni Luigi De Maria
    • Contact: Giovanni Luigi De Maria, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
3. Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
4. Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline

Exclusion Criteria:

1. Individual lacks appropriate renal artery anatomy
2. Individual has undergone prior renal denervation
3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
5. Individual has an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2
6. Individual has one or more episode(s) of orthostatic hypotension
7. Individual is pregnant, nursing or planning to become pregnant
8. Individual has documented primary pulmonary hypertension
9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SWYFT cohort; Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)	Device: Symplicity Spyral™ multi-electrode renal denervation system; After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.; Other Names: Renal Denervation; Renal Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.	Procedure
Office Systolic Blood Pressure Change	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).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Office Systolic Blood Pressure change	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change in blood pressure as measured by 24-hour ABPM	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Time subject's blood pressure is controlled	Procedure to 36 months post-procedure
Change in number of anti-hypertensive medications taken from baseline	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Evaluation of slope of eGFR	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Home Blood Pressure change	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Evaluate factors influencing blood pressure response to renal denervation	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Incidence of safety events, including major adverse events	From baseline to 3, 6, 12, 24, and 36 months post-procedure
Change from baseline in hypertension health status score	From baseline to 3, 6, 12, 24, and 36 months post-procedure. A higher score means a better outcome.

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: David Lee, MD, Stanford University; Principal Investigator: Konstantinos Tsioufis, Prof Dr, Hippokration General Hospital of Athens

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 24, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertension; Cardiovascular Diseases; Diabetes Mellitus; Vascular Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: MDT20044RDN004_SWYFT; SPYRAL AFFIRM (NCT05198674) (Other Identifier: ClinicalTrials.gov); CIV-21-09-037767 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data. Aggregate results will be made publicly available via publications and conference presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No