A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

Exclusion Criteria

• •Lacks appropriate renal artery anatomy for renal denervation
• •Secondary hypertension other than sleep apnea
• •Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
• •Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
• •Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
• •Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
• •Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
• •Patients with a history of persistent or permanent atrial tachyarrhythmia
• •Patients with active implantable medical devices
• •Primary pulmonary hypertension
• •Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
• •Night shift workers
• •Pregnant, nursing or planning to become pregnant
• •Patients with any of the following central laboratory tests at screening
• •* Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
• •* HbA1c greater than or equal to 8.0%
• •* eGFR less than 40 mL/min/1.73m2