NCT07115953Recruiting
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 22 Sept 2025
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Medtronic Vascular
- NCT number
- NCT07115953
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 22 Sept 2025 to the primary completion date, 30 Oct 2027
- 21 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individual has undergone prior renal denervation
Other illness
- Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
- Individual has documented primary pulmonary hypertension
Lab values
- Individual has an estimated glomerular filtration rate (eGFR) of \<45 mL/min/1.73m2
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Other
- Individual lacks appropriate renal artery anatomy
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Algemeen Stedelijk Ziekenhuis - campus Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| AZ Sint-Jan Brugge-Oostende AV Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Universitätsklinikum Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Universität Des Saarlandes Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Leipzig Heart Institute Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Sana Kliniken Lübeck GmbH Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
| Schwarzwald-Baar Klinikum Villingen-Schwenningen Coordinator of this site? Confirm its status | Villingen-Schwenningen | Germany | Recruiting |
| Oxford University Hospitals NHS Trust, John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Hippokration General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Terminated |
| Sarawak Heart Center Coordinator of this site? Confirm its status | Kota | Malaysia | Recruiting |
| Institut Jantung Negara - National Heart Institute Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Zuyderland Medisch Centrum - Heerlen Coordinator of this site? Confirm its status | Heerlen | Netherlands | Recruiting |
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| MacKay Memorial Hospital, Tamsui Branch Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.