Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension

Launched by MEDTRONIC VASCULAR · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial, called SPYRAL SWYFT, is studying a treatment for people with uncontrolled high blood pressure (hypertension). The treatment uses a special device called the Symplicity Spyral system to perform a procedure called renal denervation, which targets nerves in the arteries of the kidneys to help lower blood pressure. This study is testing a new way of doing the procedure that may take less time but still work just as well as earlier methods.

People who might be eligible for this trial are adults aged 65 to 74 who have high blood pressure that is not well controlled, confirmed by measurements taken at the doctor’s office and at home. Participants will need to have a healthy enough kidney artery structure and not have certain health issues like very poor kidney function, severe lung problems, or certain types of diabetes. If chosen, participants can expect a procedure that aims to reduce their blood pressure by targeting kidney nerves, and their blood pressure will be carefully monitored before and after the treatment to see how well it works. This study is not yet recruiting but is focused on finding a faster, effective treatment option for people struggling with high blood pressure.

Gender

ALL

Eligibility 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%