Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Recruiting · NCT07115953 · Interventional (participants receive a specific treatment) · Lead sponsor: Medtronic Vascular
View the official record on ClinicalTrials.gov →Interventions studied
Symplicity Spyral™ multi-electrode renal denervation system
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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%
Where it is running
21 locations listed.
- Algemeen Stedelijk Ziekenhuis - Campus Aalst - Aalst, Belgium
- Hippokration General Hospital of Athens - Athens, Greece
- AZ Sint Jan Brugge-Oostende av - Bruges, Belgium
- Universitätsklinikum Erlangen - Erlangen, Germany
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Zuyderland Medisch Centrum Heerlen - Heerlen, Netherlands
- Sarawak Heart Center - Kota, Malaysia
- Institut Jantung Negara - National Heart Institute - Kuala Lumpur, Malaysia
- Leipzig Heart Institute - Leipzig, Germany
- The Alfred Hospital - Melbourne, Australia
- Oxford University Hospitals NHS Trust - John Radcliffe Hospital - Oxford, United Kingdom
- Royal Perth Hospital - Perth, Australia
- Erasmus University Medical Center - Rotterdam, Netherlands
- MacKay Memorial Hospital, Tamsui Branch - Taipei, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Schwarzwald-Baar Klinikum Villingen-Schwenningen - Villingen-Schwenningen, Germany
- Mater Misericordiae University Hospital - Dublin, Dublin, Ireland
- Ziekenhuis Oost Limburg - Genk, Limburg, Belgium
- CHC MontLégia - Liège, Liège, Belgium
- Universitat des Saarlandes - Homburg, Saarland, Germany
- Sana Kliniken Lübeck GmbH - Lübeck, Schleswig-Holstein, Germany