Sympathy Redo: redo of renal denervation with a second generation device. - Sympathy Redo

niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1.Individual is *18 years of age.
•2. Individual has a mean day-time SBP * 135 mmHg, as determined with the use of ABPM, while the patient uses 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs (ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
•3. Individual has been treated with renal denervation as treatment for hypertension * 12 months prior for inclusion.
•4. Individual has been treated with renal denervation, performed with the Symplicity Flex catheter.
•5. Individual has a decrease in systolic ABPM < 10 mmHg compared to baseline.;The inclusion criteria are the same as for the Sympathy study, plus the addition of the last three criteria.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:;1. Individual is unable or unwilling to sign informed consent.
•2. Individual has a treatable secondary cause of hypertension
•3. Individual has an eGFR below 20 mL/min/1.73m2 using the MDRD calculation.
•4. Individual has renal artery anatomy that is ineligible for treatment.
•5. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
•6. Individual is pregnant, nursing or planning to be pregnant.
•7. Individual participates (participated) in the Sympathy study.;The exclusion criteria are the same as for the Sympathy study plus the last criteria.

发起方

niversitair Medisch Centrum Utrecht