- Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT07115953.
- What is being tested: The Symplicity Spyral catheter system for renal denervation targeting the main and first-order branch renal arteries to achieve shorter procedure times whilst maintaining efficacy in blood pressure reduction for uncontrolled hypertension.
- Patient eligibility overview: Subjects with uncontrolled hypertension who meet criteria for renal denervation therapy, though specific inclusion/exclusion parameters are not fully detailed in the provided summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
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- Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg
- Individual has a baseline office diastolic blood pressure ≥ 90 mmHg
- Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)
- Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.