Actively Recruiting
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Led by Medtronic Vascular · Updated on 2026-05-06
130
Participants Needed
19
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hypertension and baseline office systolic blood pressure 140 mmHg
- Baseline office diastolic blood pressure 90 mmHg
- Average systolic baseline home blood pressure 135 mmHg with at least 7 days of valid pre-procedure measurements
- Valid 24-hour ambulatory blood pressure measurement at baseline
You will not qualify if you...
- Inappropriate renal artery anatomy
- Prior renal denervation procedure
- Condition preventing accurate blood pressure measurement
- Requires chronic oxygen support or mechanical ventilation except nocturnal support for sleep apnea
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2
- One or more episodes of orthostatic hypotension
- Pregnant, nursing, or planning pregnancy
- Documented primary pulmonary hypertension
- Documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
The Alfred Hospital
Melbourne, Australia
Actively Recruiting
2
Royal Perth Hospital
Perth, Australia
Actively Recruiting
3
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600
Actively Recruiting
4
Algemeen Stedelijk Ziekenhuis - Campus Aalst
Aalst, Belgium
Actively Recruiting
5
AZ Sint Jan Brugge-Oostende av
Bruges, Belgium, 8000
Actively Recruiting
6
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
7
CHC MontLégia
Liège, Belgium, 4000
Actively Recruiting
8
Universitat des Saarlandes
Homburg, Saarland, Germany, 66123
Actively Recruiting
9
Sana Kliniken Lübeck GmbH
Lübeck, Schleswig-Holstein, Germany, 23560
Actively Recruiting
10
Universitätsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
11
Leipzig Heart Institute
Leipzig, Germany
Actively Recruiting
12
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Actively Recruiting
13
Mater Misericordiae University Hospital
Dublin, Ireland, D07 R2WY
Terminated
14
Sarawak Heart Center
Kota, Malaysia
Actively Recruiting
15
Zuyderland Medisch Centrum Heerlen
Heerlen, Netherlands, 6419 PC
Actively Recruiting
16
Erasmus University Medical Center
Rotterdam, Netherlands
Actively Recruiting
17
MacKay Memorial Hospital, Tamsui Branch
Taipei, Taiwan
Actively Recruiting
18
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
19
Oxford University Hospitals NHS Trust - John Radcliffe Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
K
Kelsey Anderson
CONTACT
C
Carly Loudoun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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