SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

Trial ID or NCT#

NCT02439749

Status

recruiting iconRECRUITING

Purpose

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

Official Title

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

Eligibility Criteria

Ages Eligible for Study: 20 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications. - Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg. - Individual is willing to discontinue current antihypertensive medications.
Exclusion Criteria:
  1. - Individual lacks appropriate renal artery anatomy. - Individual has estimated glomerular filtration rate (eGFR) of <45. - Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus. - Individual has one or more episodes of orthostatic hypotension. - Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. - Individual has primary pulmonary hypertension. - Individual is pregnant, nursing or planning to become pregnant. - Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment. - Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. - Individual works night shifts.
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Investigator(s)

Alan Yeung, MD
Alan Yeung, MD
Interventional cardiologist, Cardiologist
Li Ka Shing Professor in Cardiology
David Lee, MD
Interventional cardiologist, Cardiologist
Associate Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

Contact

Maria E Perlas
650-723-2094

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View on ClinicalTrials.gov