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NCT07115953
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Medtronic Vascular
Location: The Alfred Hospital Melbourne
Summary
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.
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 \
Source: ClinicalTrials.gov (NCT07115953). StuddyBuddy aggregates publicly available trial information.