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A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit in Subjects with Hypertension

The purpose of this study is to evaluate the safety and effectiveness of renal denervation while still on blood pressure medications. Renal denervation is the destruction of nerve fibers that run along the kidney blood vessels. This causes an interruption of nerve signals that may cause high blood pressure. Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces blood pressure.

Attend all visits, undergo an magnetic resonance angiography (MRA) or computed tomography angiography (CTA) and an electrocardiography (ECG) answer questions about health honestly and completely, and follow the instructions given by the study doctor, complete the subject diary

$800

Umar Farooq
Paula Trump - at PSHVIResearchCoordinators@pennstatehealth.psu.edu or 717-531-5967
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02910414
STUDY00012450
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Inclusion Criteria:
age 18-80
Have high blood pressure despite taking blood pressure medicine
You are taking 2-5 antihypertensive medications
Exclusion Criteria:
Have had removal of a kidney or kidney transplant
You have type 1 diabetes or severe type 2
Have severe untreated obstructive sleep apnea
Bleeding disorder
Heart & Vascular
Experimental device
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,