Interventional Cardiology - SPYRAL AFFIRM
The purpose of this study is to study renal denervation with the Symplicity Spyral Renal Denervation system in patients with hypertension in which lifestyle changes and hypertensive medications cannot control blood pressure.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Individual has an estimated glomerular filtration rate (eGFR) of <45
- Individual has one or more episode(s) of orthostatic hypotension
- Individual is pregnant, nursing or planning to become pregnant
- Individual has primary pulmonary hypertension
- Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
Location: Hartford Hospital
Sponsor: Medtronic
Contact: Jadwiga Jerman 860-972-9146 jadwiga.jerman@hhchealth.org