Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

Study Overview
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Brief Summary
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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
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Inclusion Criteria Individual is 18 years of age. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. Patient scheduled for renal sympathetic denervation using market-released device. Exclusion Criteria 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. 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.).

Official Title
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Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity

Conditions
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Hypertension, Heart Failure, Chronic Kidney Disease, Diabetes, Heart Rhythm Disorders

Intervention / Treatment
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* Device: Renal denervation with Symplicity Flex Medtronic/Ardian
* Device: Renal denervation with EnligHTN St. Jude Medical
* Device: Renal denervation with Paradise Recor
* Device: Renal denervation with V2 Vessix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Individual is 18 years of age. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. Patient scheduled for renal sympathetic denervation using market-released device. Exclusion Criteria 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. 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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter-based renal denervation<br>One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix | Device: Renal denervation with Symplicity Flex Medtronic/Ardian<br>* Renal denervation using CE-marked devices will be performed according to best medical practice.<br>Device: Renal denervation with EnligHTN St. Jude Medical<br>* Renal denervation using CE-marked devices will be performed according to best medical practice.<br>Device: Renal denervation with Paradise Recor<br>* Renal denervation using CE-marked devices will be performed according to best medical practice.<br>Device: Renal denervation with V2 Vessix<br>* Renal denervation using CE-marked devices will be performed according to best medical practice.<br>|
| No Intervention: Medical therapy<br>Best medical therapy using guideline recommended drugs in each disease state. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Heart Failure, Sympathetic activity