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Clinical Trial ยท NA ยท Recruiting

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

16 October 2026 NCT07115953 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
NA
Participants
ALL
Age Range
18 Years+

About This Trial

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.

Who Can Join?

Inclusion Criteria: 1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure โ‰ฅ140 mmHg 2. Individual has a baseline office diastolic blood pressure โ‰ฅ 90 mmHg 3. Individual has an average systolic baseline home blood pressure โ‰ฅ135 mmHg (with โ‰ฅ7 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

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