The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.
Inclusion Criteria 1. Individual is 18 years of age. 2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. 3. Patient scheduled for renal sympathetic denervation using market-released device. Exclusion Criteria 1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair. 2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation using CE-marked devices will be performed according to best medical practice.
University Hospital Saarland
Homburg/Saar, Germany
RECRUITINGSafety and efficacy of renal denervation
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Time frame: Baseline to 6 months
Effect of renal denervation on different organ systems.
Myocardial function and geometry using echo and MRI. Heart rate changes and arrhythmias. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Time frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Safety and efficacy of renal denervation
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Time frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
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Renal denervation using CE-marked devices will be performed according to best medical practice.