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HypertensionSWYFTNCT07115953

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

A study testing Symplicity Spyral™ multi-electrode renal denervation system in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 21 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Symplicity Spyral™ multi-electrode renal denervation system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
21 sitesin 9 countries
Study dates
22 Sep 2025to 30 Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

21 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Adela Martinez Sanchez contact

+31 43 356 6566

adela.h.martinezsanchez@medtronic.com

Carly Loudoun contact

+31 43 356 6566

rs.spyralaffirm@medtronic.com

21 sites in 9 countries

Belgium5 sites, 5 recruiting

  • Algemeen Stedelijk Ziekenhuis - Campus Aalst

    Aalst

    Jan Debrauwere, MD

    Jan Debrauwere, MD

    Recruiting

  • AZ Sint Jan Brugge-Oostende av

    Bruges, 8000

    Jan Van Der Hyden, MD

    Jan Van Der Hyden, MD

    Recruiting

  • Ziekenhuis Oost Limburg

    Genk, Limburg, 3600

    Koen Ameloot, MD

    Koen Ameloot, MD

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Benny Drieghe, MD

    Benny Drieghe, MD

    Recruiting

  • CHC MontLégia

    Liège, Liège, 4000

    Pieter-Jan Palmers, MD

    Pieter-Jan Palmers, MD

    Recruiting

Other trials in Belgium

Germany5 sites, 5 recruiting

  • Universitätsklinikum Erlangen

    Erlangen

    Roland Schmeider, MD

    Roland Schmeider, MD

    Recruiting

  • Universitat des Saarlandes

    Homburg, Saarland, 66123

    Bakuradze Tamara

    Michael Böhm, MD

    Recruiting

  • Leipzig Heart Institute

    Leipzig

    Karl Fengler, MD

    Karl Fenger, MD

    Recruiting

  • Sana Kliniken Lübeck GmbH

    Lübeck, Schleswig-Holstein, 23560

    Joachim Weil, MD

    Tolga Agdirlioglu, MD

    Recruiting

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen

    Villingen-Schwenningen

    Sebastian Ewen, Prof. Dr.

    Sebastian Ewen, Prof. Dr.

    Recruiting

Other trials in Germany

Australia2 sites, 2 recruiting

  • The Alfred Hospital

    Melbourne

    Tony Walton, MD

    Tony Walton, MD

    Recruiting

  • Royal Perth Hospital

    Perth

    Markus Schlaich, MD

    Markus Schlaich, MD

    Recruiting

Other trials in Australia

Malaysia2 sites, 2 recruiting

  • Sarawak Heart Center

    Kota

    Ong Tiong Kiam, MD

    Ong Tiong Kiam

    Recruiting

  • Institut Jantung Negara - National Heart Institute

    Kuala Lumpur, 50400

    Renobastian Nur Syamsi, +60 326178200, renobastian@ijn.com.my

    Amin Ariff Nuruddin, Dr

    Recruiting

Other trials in Malaysia

Netherlands2 sites, 2 recruiting

  • Zuyderland Medisch Centrum Heerlen

    Heerlen, 6419 PC

    Saman Rasoul, MD

    Saman Rasoul, MD

    Recruiting

  • Erasmus University Medical Center

    Rotterdam

    Joost Daemen, MD, PhD, +31 10 70 393 07, j.daemen@erasmusmc.nl

    Joost Daemen, MD, PhD

    Recruiting

Other trials in Netherlands

Taiwan2 sites, 2 recruiting

  • MacKay Memorial Hospital, Tamsui Branch

    Taipei

    Ying-Hsiang Lee, Dr.

    Yuping (Alice) Huang

    Recruiting

  • National Taiwan University Hospital

    Taipei

    Tzung-Dau Wang, Prof. Dr.

    Yachun Chen

    Recruiting

Other trials in Taiwan

Greece1 site, 1 recruiting

  • Hippokration General Hospital of Athens

    Athens, 11527

    Fotis Tatakis

    Konstantinos Tsioufis, Prof Dr

    Recruiting

Other trials in Greece

Ireland1 site

  • Mater Misericordiae University Hospital

    Dublin, Dublin, D07 R2WY

    Terminated

Other trials in Ireland

United Kingdom1 site, 1 recruiting

  • Oxford University Hospitals NHS Trust - John Radcliffe Hospital

    Oxford

    Giovanni Luigi De Maria, MD

    Giovanni Luigi De Maria

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Symplicity Spyral™ multi-electrode renal denervation system
Medical subject headings
Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Symplicity Spyral™ multi-electrode renal denervation systemDevice

    Also called Renal Angiography, Renal Denervation

    After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Study groups in NCT07115953
Study groupRoleWhat they receive
SWYFT cohortExperimentalRenal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Receives: Device: Symplicity Spyral™ multi-electrode renal denervation system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure time

    Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.

    Measured: Procedure

  2. 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).

    Measured: 6 months

Secondary outcomes (10)

  1. Office Systolic Blood Pressure change

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  2. Home Blood Pressure change

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  3. Change in blood pressure as measured by 24-hour ABPM

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  4. Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  5. Time subject's blood pressure is controlled

    Measured: Procedure to 36 months post-procedure

  6. Change in number of anti-hypertensive medications taken from baseline

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  7. Change from baseline in hypertension health status score

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure. A higher score means a better outcome.

  8. Evaluate factors influencing blood pressure response to renal denervation

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  9. Evaluation of slope of eGFR

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

  10. Incidence of safety events, including major adverse events

    Measured: From baseline to 3, 6, 12, 24, and 36 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start22 Sep 2025
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07115953
Sponsor's protocol ID
MDT20044RDN004_SWYFT
Other IDs
SPYRAL AFFIRM (NCT05198674), CIV-21-09-037767
Acronym
SWYFT
Status last verified
Oct 2026
First submitted
24 Jul 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data. Aggregate results will be made publicly available via publications and conference presentations.

Questions about this trial

What is this clinical trial studying?

A study testing Symplicity Spyral™ multi-electrode renal denervation system in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 21 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Belgium, Germany, Australia, Malaysia, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adela Martinez Sanchez (+31 43 356 6566, adela.h.martinezsanchez@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure time (time frame: Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07115953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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