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

NCT07115953 · tracked via the Priya Life Science Australia tracker

Sponsor

Medtronic Vascular

Phase

Not applicable

Started

2025-09-22

Last updated

2026-06-30

Condition(s) studied

HypertensionVascular DiseasesCardiovascular DiseasesChronic Kidney DiseasesDiabetes Mellitus

Investigational drug(s) / intervention(s)

Symplicity Spyral™ multi-electrode renal denervation system

Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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%

Primary outcome measure(s)

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).

Trial sites (21)

Facility	City	Region	Status
The Alfred Hospital	Melbourne	Australia	Recruiting
Royal Perth Hospital	Perth	Australia	Recruiting
Ziekenhuis Oost Limburg	Genk	Limburg	Recruiting
CHC MontLégia	Liège	Liège	Recruiting
Algemeen Stedelijk Ziekenhuis - Campus Aalst	Aalst	Belgium	Recruiting
AZ Sint Jan Brugge-Oostende av	Bruges	Belgium	Recruiting
Universitair Ziekenhuis Gent	Ghent	Belgium	Recruiting
Universitat des Saarlandes	Homburg	Saarland	Recruiting
Sana Kliniken Lübeck GmbH	Lübeck	Schleswig-Holstein	Recruiting
Universitätsklinikum Erlangen	Erlangen	Germany	Recruiting
Leipzig Heart Institute	Leipzig	Germany	Recruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen	Villingen-Schwenningen	Germany	Recruiting
Hippokration General Hospital of Athens	Athens	Greece	Recruiting
Mater Misericordiae University Hospital	Dublin	Dublin	Terminated
Sarawak Heart Center	Kota	Malaysia	Recruiting
Institut Jantung Negara - National Heart Institute	Kuala Lumpur	Malaysia	Recruiting
Zuyderland Medisch Centrum Heerlen	Heerlen	Netherlands	Recruiting
Erasmus University Medical Center	Rotterdam	Netherlands	Recruiting
MacKay Memorial Hospital, Tamsui Branch	Taipei	Taiwan	Recruiting
National Taiwan University Hospital	Taipei	Taiwan	Recruiting
Oxford University Hospitals NHS Trust - John Radcliffe Hospital	Oxford	United Kingdom	Recruiting

More Medtronic Vascular trials in Australia

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN Active, not recruiting

SPYRAL GEMINI Pilot Study Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07115953 on ClinicalTrials.gov ↗ ← All trials in Australia