Streamlined renal denervation with Spyral for uncontrolled high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Alfred Hospital
  Melbourne, Australia Recruiting
• Royal Perth Hospital
  Perth, Australia Recruiting
• Ziekenhuis Oost Limburg
  Genk, Limburg, Belgium Recruiting
• CHC MontLégia
  Liège, Liège, Belgium Recruiting
• Algemeen Stedelijk Ziekenhuis - Campus Aalst
  Aalst, Belgium Recruiting
• AZ Sint Jan Brugge-Oostende av
  Bruges, Belgium Recruiting

Study contacts

• Principal investigator: David Lee, MD — Stanford University
• Study coordinator: Adela Martinez Sanchez
• Email: adela.h.martinezsanchez@medtronic.com
• Phone: +31 43 356 6566

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.