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.
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
Individual lacks appropriate renal artery anatomy
Individual has undergone prior renal denervation
Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement
Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
Single group
Symplicity Spyral™ multi-electrode renal denervation system
DeviceAfter a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Procedure time
Procedure time will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED procedure times.
Office Systolic Blood Pressure Change
Office Systolic Blood Pressure (OSBP) change from baseline to 6 months will be compared to the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED study efficacy endpoints using a propensity score stratified baseline blood pressure adjusted analysis at 3 months (OFF MED) and 6 months (ON MED).
Office Systolic Blood Pressure change
Home Blood Pressure change
Change in blood pressure as measured by 24-hour ABPM
Percent of subjects achieving blood pressure control as measured by OBP, HBP and ABPM
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