♥ Aktuelle Studien

Inclusion criteria (TRIO cohort of the RADIANCE-HTN study}:

• All subjects have to be between 18 and 75 years old at the time of consent and sign the patient informed consent. Further eligible subjects have to meet all of the following inclusion criteria:
• Subject has a documented history of essential hypertension .
• Subject has an average seated office BP ≥140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
• Subject has a documented daytime ABP ≥135/85 mmHg and <170/105 mm Hg after 4-week stabilization period.
• Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (:51 year) renal imaging).
• Subject is willing and able to comply with all study procedures.

Inclusion criteria (RADIANCE-II pivotal study):

• All subjects have to be between 18 and 75 years old at the time of consent and sign the patient informed consent. Further eligible subjects have to meet all of the following inclusion criteria:
• Subjects have been prescribed antihypertensive therapy previously or are currently prescribed antihypertensive therapy.
• Subject has an average seated office BP ≥140/90 mmHg at screening visit while on a stable regimen for at least 4 weeks on 0-2 classes of antihypertensive medication.
• Subject has a documented daytime ABP ≥135/85 mmHg and <170/105 mmHg after 4-week wash-out/run-in period.

If any of the following criteria are met, the subject is excluded from the study.

• Subject lacks appropriate renal artery anatomy for treatment.
• Subject has an estimated glomerular filtration rate (eGFR) of <40mL/min/1.73 m²
• Subject has evidence of active infection within 7 days of procedure.
• Subject has secondary hypertension not including sleep apnea.
• Subject has iliac/femoral artery stenosis precluding insertion of the Paradise catheter.
• Subject has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus.
• Subject has documented history of chronic active bowel disorders.
• Subject has brachia! circumference ≥42 cm.
• Subject has any history of cerebrovascular event within 3 months prior to consent.
• Subject has any history of severe cardiovascular event within 3 months prior to consent.
• Subject has documented confirmed episode(s) of unstable angina within 3 months prior to consent.
• Subject has documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol.
• Subject has documented history of persistent or permanent atrial tachyarrhythmia.
• Subject has active implantable medical device (e.g. ICD or CRT-D).
• Subject has chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
• Subject has primary pulmonary hypertension.
• Subject has documented contraindication or allergy to contrast medium not amenable to treatment.
• Subject has limited life expectancy of <1 year at the discretion of the investigator.
• Subject has any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any other reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers).
• Subject is pregnant, nursing or planning to become pregnant (documented negative pregnancy test required within a maximum of 7 days prior to the procedure for all women of child bearing potential.
• Subject is enrolled in any other concurrent investigational drug or device trial (participation in non-interventional registries acceptable).