Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- University Hospital, Saarland
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Safety and efficacy of renal denervation
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety and efficacy of renal denervation
Time Frame: Baseline to 6 months
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.
Secondary Outcomes
- Effect of renal denervation on different organ systems.(Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months)
- Safety and efficacy of renal denervation(Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months)