Streamlined renal denervation with Spyral for uncontrolled high blood pressure
Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)
NA · Medtronic Vascular · NCT07115953
This trial will test whether a shorter, simpler renal denervation procedure using the Symplicity Spyral system can lower blood pressure in adults with uncontrolled hypertension.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Vascular (industry) |
| Locations | 19 sites (Melbourne and 18 other locations) |
| Trial ID | NCT07115953 on ClinicalTrials.gov |
What this trial studies
SPYRAL SWYFT compares a streamlined renal denervation approach that targets the main and first-order branch renal arteries with the prior approach that ablated all accessible renal arterial vessels between 3 and 8 mm. The study uses the Symplicity Spyral multi-electrode system and records procedure time, ambulatory and office blood pressure, and long-term safety and durability. Eligible participants must have uncontrolled hypertension meeting office, home, and 24-hour ambulatory BP thresholds, and those with prior renal denervation or unsuitable renal anatomy are excluded. The sub-study is conducted under the SPYRAL AFFIRM protocol across participating centers in the EU and APAC regions.
Who should consider this trial
Good fit: Adults with uncontrolled hypertension who meet office, home, and 24-hour ambulatory BP thresholds, have suitable renal artery anatomy, and have not had prior renal denervation are ideal candidates.
Not a fit: Patients with unsuitable renal artery anatomy, prior renal denervation, significantly reduced kidney function (eGFR <45 mL/min/1.73 m2), pregnancy, chronic ventilation needs, or conditions preventing accurate blood pressure measurement are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could shorten treatment time while maintaining similar blood pressure lowering, making renal denervation quicker and more convenient for patients and clinicians.
How similar studies have performed: Prior SPYRAL trials (HTN-ON MED and PIVOTAL/HTN-OFF MED) showed blood pressure reductions with the Symplicity Spyral system, and this sub-study tests a procedural simplification built on those findings.
Eligibility criteria
Show full inclusion / exclusion 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%
Where this trial is running
Melbourne and 18 other locations
- The Alfred Hospital — Melbourne, Australia (RECRUITING)
- Royal Perth Hospital — Perth, Australia (RECRUITING)
- Ziekenhuis Oost Limburg — Genk, Limburg, Belgium (RECRUITING)
- Algemeen Stedelijk Ziekenhuis - Campus Aalst — Aalst, Belgium (RECRUITING)
- AZ Sint Jan Brugge-Oostende av — Bruges, Belgium (RECRUITING)
- Universitair Ziekenhuis Gent — Ghent, Belgium (RECRUITING)
- CHC MontLégia — Liège, Belgium (RECRUITING)
- Universitat des Saarlandes — Homburg, Saarland, Germany (RECRUITING)
- Sana Kliniken Lübeck GmbH — Lübeck, Schleswig-Holstein, Germany (RECRUITING)
- Universitätsklinikum Erlangen — Erlangen, Germany (RECRUITING)
- Leipzig Heart Institute — Leipzig, Germany (RECRUITING)
- Schwarzwald-Baar Klinikum Villingen-Schwenningen — Villingen-Schwenningen, Germany (RECRUITING)
- Mater Misericordiae University Hospital — Dublin, Ireland (TERMINATED)
- Sarawak Heart Center — Kota, 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)
Study contacts
- Principal investigator: David Lee, MD — Stanford University
- Study coordinator: Kelsey Anderson
- Email: rs.spyralaffirm@medtronic.com
- Phone: 651 247 5268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus