RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Medtronic Vascular • ClinicalTrials.gov ID: NCT07115953

Registry updated: 2026-10-16

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

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

Eligibility criteria

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%

Conditions

Hypertension Vascular Diseases Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus

Locations

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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment