Chronic Kidney Disease, Diabetes, Heart Failure, Heart Rhythm Disorders, Hypertension
Conditions
Keywords
Hypertension, Heart Failure, Sympathetic activity
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.).
Interventions
DEVICERenal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation using CE-marked devices will be performed according to best medical practice.
DEVICERenal denervation with EnligHTN St. Jude Medical
Renal denervation using CE-marked devices will be performed according to best medical practice.
DEVICERenal denervation with Paradise Recor
Renal denervation using CE-marked devices will be performed according to best medical practice.
DEVICERenal denervation with V2 Vessix
Renal denervation using CE-marked devices will be performed according to best medical practice.
Sponsors
University Hospital, Saarland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and efficacy of renal denervation | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of renal denervation on different organ systems. | Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months | 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). |
| Safety and efficacy of renal denervation | Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 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. |
Countries
Germany
Contacts
Primary ContactFelix Mahfoud, MD
Backup ContactMichael Böhm, MD
Outcome results
None listed