Tests a streamlined kidney nerve procedure for uncontrolled high blood pressure
Tests a faster kidney nerve procedure in adults with uncontrolled high blood pressure.
Plain-language title generated from the registry record
Registry title: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Key facts
- Where
- Aalst, Bruges, Genk, Ghent, and Liège, BelgiumSee the 5 sites
Where in Belgium
- Algemeen Stedelijk Ziekenhuis - campus AalstAalst, BelgiumTaking people
- AZ Sint-Jan Brugge-Oostende AVBruges, BelgiumTaking people
- Ziekenhuis Oost-LimburgGenk, BelgiumTaking people
- Universitair Ziekenhuis GentGhent, BelgiumTaking people
- CHC MontLégiaLiège, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Vascular
- Trial code
- NCT07115953
- Record updated
- 16 October 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: 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 has documented primary pulmonary hypertension; 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%; 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.